Acceptance Test Kit

Release 5.2.0

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Nov 01, 2019

Abstract

This guide describes the DFdiscover Acceptance Test Kit.


Table of Contents

Preface
1. Getting Help
2. Conventions
I. Preliminaries
1. Introduction
1.1. Objective
1.2. Approach
1.3. The Kit
1.4. Instructions
1.5. Notes
1.6. How to start DFexplore
1.7. How to Start DFsetup
1.8. How to start DFsend
2. ATK Worksheet
2.1. Using the Worksheet
2.2. Module 1: Installation and Initialization
2.3. Module 2: DFexplore Client Applications
2.4. Module 3: Study Setup
2.5. Module 4: EDC Data Entry
2.6. Module 5: Image Data Entry
2.7. Module 6: User-Defined Query Category Types
2.8. Module 7: Multiple Queries Per Field
2.9. Module 8: Double Data Entry (DDE)
2.10. Module 9: Data Review
2.11. Module 10: External Query Reports
2.12. Module 11: Replying to EDC Queries, eSignatures
2.13. Module 12: Re-submitting CRFs and Correcting Queries
2.14. Module 13: Data Export and DFsas
2.15. Module 14: PDF File Creation
2.16. Module 15: eCRF Creation for DFdiscover
2.17. Module 16: DFweb Data Entry
2.18. Module 17: DFcollect Mobile Data Collection
2.19. Module 18: User-defined Property Tags
2.20. Signature and Date
3. Discrepancy Report
3.1. Problem
3.2. Immediate Workaround
3.3. Problem Resolution
3.4. Signature and Date
II. Modules
1. Module 1: Installation and Initialization
1.1. Tests & Requirements
1.2. Confirm version information can be obtained for DFdiscover.
1.3. Obtain super-user privileges and remove older Acceptance Test Study, if one exists.
1.4. Install the Acceptance Test Study.
1.5. Define Acceptance Test Study to the DFdiscover server.
1.6. Create a role and permissions for valid1.
1.7. Create a DFdiscover account for valid1.
1.8. Create a role and permissions for datafax.
1.9. Enable high definition imaging.
1.10. Start the Acceptance Test Study Control Panel application.
2. Module 2: DFexplore Client Applications
2.1. Tests & Requirements
2.2. Begin Module 2.
2.3. Send PDF images to DFexplore.
2.4. Verify the on-line user documentation. Open the Image Router and verify the appearance of the Welcome Image.
2.5. Open the Acceptance Test Study and verify the standard DFexplore views.
2.6. Start DFsetup and verify version information.
2.7. Login and verify the on-line setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.
2.8. End Module 2.
3. Module 3: Study Setup
3.1. Tests & Requirements
3.2. Begin Module 3.
3.3. Permitted users can gain exclusive access to DFsetup to modify a study setup.
3.4. Define Global study preferences and apply settings to DFsetup.
3.5. Create and modify a new style (Comment).
3.6. Create and modify a new module (Death).
3.7. Assign Field definitions to a newly created module.
3.8. Assign a module's field definitions to a plate.
3.9. Correct field ordering on the current plate to set fixed field traversal order for data entry.
3.10. Use copy and paste to create repeating module and field references on a plate.
3.11. Create user-defined query category codes.
3.12. Submit a copy of the newly setup Plate 11 into the study database and retrieve the page in DFexplore Image View.
3.13. Enter and save all data on the submitted plate 11.
3.14. End Module 3.
4. Module 4: EDC Data Entry
4.1. Tests & Requirements
4.2. Begin Module 4.
4.3. Login to DFexplore and inspect the list of sites, subjects and visits in the record list window.
4.4. Enter and save new data using EDC data entry for Subject 99007.
4.5. Add reasons to explain entered data values.
4.6. Enter and save Plate 3, Subject 99007 as a pending record.
4.7. Mark and save unavailable data as missed. Unmark available data as missed.
4.8. Retrieve and modify existing data using a predefined task and save modifications to the database.
4.9. Confirm audit trail information for entered and modified data.
4.10. End Module 4.
5. Module 5: Image Data Entry
5.1. Tests & Requirements
5.2. Begin Module 5
5.3. Send PDF images to DFexplore.
5.4. Login to DFexplore and confirm the receipt of new pages in the Status View.
5.5. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.
5.6. Login to DFexplore and confirm receipt of the routed page in the Status View.
5.7. Retrieve new images in DFexplore Image View.
5.8. Enter Plate 1 (Form 1) for Subject 99002.
5.9. Enter Plate 2 (Form 2) for Subject 99002.
5.10. Enter Plate 3 (Form 3) for Subject 99002.
5.11. Enter Plate 4 (Form 4) for Subject 99002.
5.12. Compare the resolutions between Standard Definition (SD) version of an image and High Definition (HD) version of the same image.
5.13. Edit an existing query.
5.14. Delete an existing query.
5.15. Change data and record a reason for data change.
5.16. Batch validate all opened pages for Subject 99002 to level 2.
5.17. Confirm the status of entered pages in Status View.
5.18. End Module 5.
6. Module 6: User-Defined Query Category Types
6.1. Tests & Requirements
6.2. Begin Module 6.
6.3. Retrieve an existing data record in DFexplore.
6.4. Apply a user-defined Query Category query.
6.5. Add a reason for Data Value to explain entered data.
6.6. Edit an existing query.
6.7. Remove a user-defined Query Category that is used by an existing query.
6.8. Delete a user-defined Query Category query.
6.9. End Module 6.
7. Module 7: Multiple Queries Per Field
7.1. Tests & Requirements
7.2. Begin Module 7.
7.3. Submit PDF images to DFexplore.
7.4. Enable multiple queries per field in DFsetup.
7.5. Retrieve submitted CRF in DFexplore Image View.
7.6. Enter Plate 9 for Subject 99002.
7.7. Apply multiple queries to a field.
7.8. Select and edit an existing query in a field that has multiple queries.
7.9. Select and reply to an existing query in a field that has multiple queries.
7.10. Select and delete an existing query in a field that has multiple queries.
7.11. End Module 7
8. Module 8: Double Data Entry (DDE)
8.1. Tests & Requirements
8.2. Begin Module 8.
8.3. Retrieve a set of records for entry by Double (2nd pass) Data Entry (DDE).
8.4. Perform DDE such that discrepancies exist between the new DDE values and the original data values.
8.5. Programmed edit checks execute as expected during DDE.
8.6. Verify the audit trail of DDE data.
8.7. End Module 8
9. Module 9: Data Review
9.1. Tests & Requirements
9.2. Begin Module 9.
9.3. Retrieve all data for Site 99 that exists at level 3.
9.4. Review and approve a pending reason for data value, and approve a selected query in a field that has multiple queries.
9.5. Review and move approved reasons for data values to a higher workflow level, and review queries in a field that has multiple queries.
9.6. Data review and add a query to inconsistent data.
9.7. Review and complete pending data for Subject 99007.
9.8. Confirm audit trail information for reviewed and modified data.
9.9. Run batch edit checks to verify data integrity.
9.10. Use a data expression to retrieve specific subject information.
9.11. Use cross-plate data criteria to retrieve specific subject information.
9.12. End Module 9.
10. Module 10: External Query Reports
10.1. Tests & Requirements
10.2. Begin Module 10.
10.3. Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.
10.4. Run database integrity check report DF_XXkeys to export all key fields and visit dates from required plates in the database.
10.5. Use Data View to check and, if necessary correct, illegal visit dates by retrieving the problems keys identified by DF_XXkeys.
10.6. Execute DF_QCupdate to update the query database and lock all records for query report generation.
10.7. Execute DF_QCreports to create a standard, 3-part external query report for a study site.
10.8. Confirm the status of external queries following query report creation.
10.9. Execute DF_QCstatus to verify that a new query report was created by listing all reports in the QC/NEW directory.
10.10. Execute DF_QCview to display the newly created query report.
10.11. Execute DF_QCprint to print the query report from the QC/NEW directory.
10.12. Comparing several examples from the printed query report against their corresponding queries in the study database.
10.13. Execute DF_QCfax to email the query report to a valid email account.
10.14. Verify the status of the queries in the sent report.
10.15. End Module 10.
11. Module 11: Replying to EDC Queries, eSignatures
11.1. Tests & Requirements
11.2. Begin Module 11.
11.3. Determine a count of outstanding/outstanding queries in Status View.
11.4. Review outstanding queries in Queries View.
11.5. Using EDC, locate and reply to outstanding clarification queries.
11.6. Add an Electronic Signature (eSign) to a set of completed subject records.
11.7. End Module 11.
12. Module 12: Re-submitting CRFs and Correcting Queries
12.1. Tests & Requirements
12.2. Begin Module 12.
12.3. Submit PDF images to DFexplore.
12.4. Verify that all CRFs have arrived successfully in Image view.
12.5. Retrieve submitted CRFs using DFexplore Image View.
12.6. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.
12.7. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.
12.8. Enter Form 4, Subject 99004.
12.9. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.
12.10. Select and resolve a query in a field that has multiple queries.
12.11. Review and approve a pending query reply for Form 1 for Subject 99002.
12.12. Review, correct and approve a pending query reply for Form 1, Subject 99007.
12.13. Confirm query resolution by examining the database status.
12.14. End Module 12.
13. Module 13: Data Export and DFsas
13.1. Tests & Requirements
13.2. Begin Module 13.
13.3. Export date values from the database in calender format and save the exported data to a file on the local computer.
13.4. Export date values from the database and save the exported data to a file on the local computer.
13.5. Examining data values according to user-specified criteria.
13.6. Query the database for specific data values.
13.7. Create a DFsas job file according to user-specified criteria.
13.8. Create a SAS job file and data files using the DFsas job file criteria.
13.9. Compare the contents of SAS data files with the actual data in the database.
13.10. End Module 13.
14. Module 14: PDF File Creation
14.1. Tests & Requirements
14.2. Begin Module 14.
14.3. Retrieving existing data according to user-specified criteria.
14.4. Saving DFexplore data to a standard PDF document.
14.5. Viewing a standard PDF data file using a PDF viewer application.
14.6. Saving DFexplore data to an encrypted bookmarked PDF file.
14.7. Open and view an encrypted bookmarked PDF file using a PDF viewer application.
14.8. Create a complete subject package PDF file that includes data records, CRF images and an audit trail.
14.9. Open and view a PDF subject package using a PDF viewer application.
14.10. End Module 14.
15. Module 15: eCRF Creation for DFdiscover
15.1. Tests & Requirements
15.2. Introduction
15.3. Begin Module 15.
15.4. eCRF creation in DFsetup.
15.5. eCRF background color preferences.
15.6. Entering eCRF data in DFexplore.
15.7. End Module 15.
16. Module 16: DFweb Data Entry
16.1. Introduction
16.2. Tests & Requirements
16.3. Begin Module 16.
16.4. Modify valid1 user permissions for DFweb entry.
16.5. Verify DFweb version information, logging into DFweb and DFweb site certificate.
16.6. Copying URL and changing user passwords.
16.7. Creating a new subject, entering subject data.
16.8. Adding, modifying and resolving queries.
16.9. Adding, reviewing and downloading subject documents.
16.10. End Module 16.
17. Module 17: DFcollect Mobile Data Collection
17.1. Introduction
17.2. Tests & Requirements
17.3. Begin Module 17.
17.4. Modify valid1 user permissions for DFcollect entry.
17.5. Installation, App preferences and initial DFcollect login.
17.6. Online data record creation.
17.7. Download subject data for offline use.
17.8. Create data records in offline mode, query resolution and adding reasons for data values.
17.9. Sync data collected offline to your DFdiscover server.
17.10. Clearing DFcollect cache.
17.11. Adding, reviewing and downloading subject documents.
17.12. Confirming data sent to the server using DFexplore.
17.13. End Module 17.
18. Module 18: User-defined Property Tags
18.1. Tests & Requirements
18.2. Begin Module 18.
18.3. Defining User-defined property tags in DFsetup.
18.4. Adding Global User-defined property values.
18.5. Adding Plate, Module and Variable level User-defined property values
18.6. Exporting User-defined property tags in DFsetup.
18.7. Edit checks execution of User-defined property tags.
18.8. Creating subject data lists and exporting data views.
18.9. DFexplore Database Definition Report exporting.
18.10. End Module 18.
A. Copyrights - Acknowledgments
A.1. External Software Copyrights
A.1.1. DCMTK software package
A.1.2. Jansson License
A.1.3. Mimencode
A.1.4. RSA Data Security, Inc., MD5 message-digest algorithm
A.1.5. mpack/munpack
A.1.6. TIFF
A.1.7. PostgreSQL
A.1.8. OpenSSL License
A.1.9. Original SSLeay License
A.1.10. gawk
A.1.11. Ghostscript
A.1.12. MariaDB and FreeTDS
A.1.13. QtAV
A.1.14. FFmpeg
A.1.15. c3.js
A.1.16. d3.js

Preface

1. Getting Help

DF/Net Research, Inc.'s Technical Support Department can be contacted Monday to Friday between 9:00 am and 5:00 pm Eastern Time via any of the following methods:


55 Head Street, Suite 403
DundasOntario  L9H 3H8
Telephone: (905) 522-3282
Email: 
URL: www.dfnetresearch.com

2. Conventions

A number of conventions have been used throughout this document.

Any freestanding sections of code are generally shown like this:

# this is example code
code = code + overhead;

If a line starts with # or %, this character denotes the system prompt and is not typed by the user.

Text may also have several styles:

  • Emphasized words are shown as follows: emphasized words.

  • Filenames appear in the text like so: dummy.c.

  • Code, constants, and literals in the text appear like so: main.

  • Variable names appear in the text like so: nBytes.

  • Text on user interface labels or menus is shown as: Printer name, while buttons in user interfaces are shown as Cancel.

  • Menus and menu items are shown as: File > Exit.

Part I. Preliminaries

Chapter 1. Introduction

1.1. Objective

The objective of the Acceptance Test Kit (ATK) is to provide DFdiscover clients with an acceptance test plan which can be executed to:

  • Verify the correct installation of the DFdiscover software in their own environment.

  • Confirm the core DFdiscover functionality in their own environment.

  • Demonstrate, by means of passed tests, correct operation of tested functionality and core requirements of the DFdiscover software.

1.2. Approach

The Acceptance Test Kit has these features:

  • Functional approach - i.e., based on meeting data management objectives.

  • Follows a logical data flow and processing path from user's viewpoint.

  • Starts with a complete study already setup using the DFdiscover software.

  • A series of tests organized within modules, are linked to the core requirements of the DFdiscover software. These modules are core to the use of the ATK. Each module has a start action, a detailed script of user steps and an end action.

  • User is given defined input and expected output for objective verification.

  • Not an exhaustive test of every button, menu or GUI in every DFdiscover application.

1.3. The Kit

The Acceptance Test Kit contains:

  • Manual: descriptions of tests, organized within functional modules.

  • Control Panel application and instructions for setting the study to base state. The Control Panel application controls the start, stop and interim states of all modules.

  • Study: simple blood pressure study already setup, which includes plate definitions, edit checks and look-up tables.

  • Database: includes several completed subject cases existing at various states (i.e., entered data, submitted and awaiting data entry, awaiting outbound transmission, or EDC data entry).

  • Case Report Forms.

1.4. Instructions

To perform the Acceptance Test Kit:

  • Module 1 provides instructions on installation and initialization. Module 1 must be completed first.

  • The Control Panel application sets each module to a known base state. Use the Begin button to start each module.

  • Modules are presented in logical order from study setup to data entry and reviews. Any module, beginning with module 2, can be skipped if it deals with topics that are not relevant to your use of the software.

  • Within each module, tests must be executed in order.

  • Execute module completion, by clicking End once all module tests have been performed.

  • Complete test summary and, if necessary, discrepancy reports.

1.5. Notes

  • Every module uses DFATK and must be run as datafax. Refer to Module 1 (Installation & Initialization).

  • References to DFdiscover Server value will be the name of your DFdiscover server.

  • Images in this manual are of the applications running in the Windows 10 operating system. If you are running the applications on macOS, the appearance of the windows, dialogs and default button layouts will differ slightly from those shown here.

  • Screen colors may appear as a black background with a white CRF foreground. These are the DFsetup default colors. The colors in illustrations have been modified (reversed) for clarity.

  • If you do not have a printer connected to the DFdiscover server (e.g. if you are a hosted client), a valid email address is required for valid1 to receive all module specific PDF files. Refer to Creating a role and permissions for Valid1, Step 5.

1.6. How to start DFexplore

  1. Start DFexplore. In the DFexplore login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  2. During the first login of valid1 a new password must be chosen. Choose and enter a new password in both the New Password and Confirm Password fields. Click OK to set the new password and dismiss the dialog. Choose 254 Acceptance Test Study, click Continue. If your DFdiscover server does not allow the re-use of previous passwords, you will be required to set valid1's password to something other than the initial password chosen previously. The password you choose must satisfy the password requirements specific to your DFdiscover server and will be needed in the remainder of the modules.

1.7. How to Start DFsetup

  1. Start DFsetup. In the DFsetup login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter valid1 or datafax in the Username field and the previously assigned password in the Password field. Click Login to login.

  2. In the studies selection dialog, highlight the entry for 254 Acceptance Test Study. Click Continue to continue.

1.8. How to start DFsend

  • Start DFsend. In the DFsend login dialog, enter the name for DFdiscover Server that has been provided by your administrator. (This will differ from the value shown here.) Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

Chapter 2. ATK Worksheet

2.1. Using the Worksheet

As you work through the ATK, you may find it beneficial to have a worksheet to keep track of which modules you have completed.

For that purpose, print this chapter and mark the steps and modules as you progress.

After completion of the ATK, complete Signature and Date and keep the printed worksheet together with your installation and qualification materials.

2.2. Module 1: Installation and Initialization

  1. Confirm version information can be obtained for DFdiscover.

  2. Obtain super-user privileges and remove older Acceptance Test Study, if one exists.

  3. Install the Acceptance Test Study.

  4. Define Acceptance Test Study to the DFdiscover server.

  5. Create a role and permissions for valid1.

  6. Create a DFdiscover account for valid1.

  7. Create a role and permissions for datafax.

  8. Enable high definition imaging.

  9. Start the Acceptance Test Study Control Panel application.

2.3. Module 2: DFexplore Client Applications

  1. Verify the on-line user documentation. Open the Image Router and verify the appearance of the Welcome Image.

  2. Open the Acceptance Test Study and verify the standard DFexplore views.

  3. Start DFsetup and verify version information.

  4. Login and verify the on-line setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.

2.4. Module 3: Study Setup

  1. Permitted users can gain exclusive access to DFsetup to modify a study setup.

  2. Define Global study preferences and apply settings to DFsetup.

  3. Create and modify a new style (Comment).

  4. Create and modify a new module (Death).

  5. Assign Field definitions to a newly created module.

  6. Assign a module's field definitions to a plate.

  7. Correct field ordering on the current plate to set fixed field traversal order for data entry.

  8. Use copy and paste to create repeating module and field references on a plate.

  9. Create user-defined query category codes.

  10. Submit a copy of the newly setup Plate 11 into the study database and retrieve the page in DFexplore Image View.

  11. Enter and save all data on the submitted plate 11.

2.5. Module 4: EDC Data Entry

  1. Login to DFexplore and the Acceptance Test Study and confirm the list of sites, subjects and assessments in the record list window.

  2. Enter and save new data using EDC data entry for Subject 99007.

  3. Add reasons to explain entered data values.

  4. Enter and save Plate 3, Subject 99007 as a pending record.

  5. Mark and save unavailable data as missed. Unmark available data as missed.

  6. Retrieve and modify existing data using a predefined task and save modifications to the database.

  7. Confirm audit trail information for entered and modified data.

2.6. Module 5: Image Data Entry

  1. Submit PDF images to DFexplore.

  2. Login to DFexplore and confirm the receipt of new pages in the Status View.

  3. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.

  4. Login to DFexplore and confirm receipt of the routed page in the Status View.

  5. Retrieve new images in DFexplore Image View.

  6. Enter Plate 1 (Form 1) for Subject 99002.

  7. Enter Plate 2 (Form 2) for Subject 99002.

  8. Enter Plate 3 (Form 3) for Subject 99002.

  9. Enter Plate 4 (Form 4) for Subject 99002.

  10. Compare the resolutions between Standard Definition (SD) version of an image and High Definition (HD) version of the same image.

  11. Edit an existing query.

  12. Delete an existing query.

  13. Change data and record a reason for data change.

  14. Batch validate all opened pages for Subject 99002 to level 2.

  15. Confirm the status of entered pages in Status View.

2.7. Module 6: User-Defined Query Category Types

  1. Retrieve an existing data record in DFexplore.

  2. Apply a user-defined Query Category query.

  3. Add a reason for Data Value to explain entered data.

  4. Edit an existing query.

  5. Remove a user-defined Query Category that is used by an existing query.

  6. Delete a user-defined Query Category query.

2.8. Module 7: Multiple Queries Per Field

  1. Submit PDF images to DFexplore.

  2. Enable multiple queries per field in DFsetup.

  3. Retrieve submitted CRF in DFexplore Image View.

  4. Enter Plate 9 for Subject 99002.

  5. Apply multiple queries to a field.

  6. Select and edit an existing query in a field that has multiple queries.

  7. Select and reply to an existing query in a field that has multiple queries.

  8. Select and delete an existing query in a field that has multiple queries.

2.9. Module 8: Double Data Entry (DDE)

  1. Retrieve a set of records for entry by Double (2nd pass) Data Entry (DDE).

  2. Perform DDE such that discrepancies exist between the new DDE values and the original data values.

  3. Programmed edit checks execute as expected during DDE.

  4. Verify the audit trail of DDE data.

2.10. Module 9: Data Review

  1. Retrieve all data for Site 99 that exists at level 3.

  2. Review and approve a pending reason for data value, and approve a selected query in a field that has multiple queries.

  3. Review and move approved reasons for data values to a higher workflow level, and review queries in a field that has multiple queries.

  4. Data review and add a query to inconsistent data.

  5. Review and complete pending data for Subject 99007.

  6. Confirm audit trail information for reviewed and modified data.

  7. Run batch edit checks to verify data integrity.

  8. Use a data expression to retrieve specific subject information.

  9. Use cross-plate data criteria to retrieve specific subject information.

2.11. Module 10: External Query Reports

  1. Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.

  2. Run database integrity check report DF_XXkeys to export all key fields and visit dates from required plates in the database.

  3. Use Data View to check and, if necessary correct, illegal visit dates by retrieving the problems keys identified by DF_XXkeys.

  4. Execute DF_QCupdate to update the query database and lock all records for query report generation.

  5. Execute DF_QCreports to create a standard, 3-part external query report for a study site.

  6. Confirm the status of external queries following query report creation.

  7. Execute DF_QCstatus to verify that a new query report was created by listing all reports in the QC/NEW directory.

  8. Execute DF_QCview to display the newly created query report.

  9. Execute DF_QCprint to print the query report from the QC/NEW directory.

  10. Comparing several examples from the printed query report against their corresponding queries in the study database.

  11. Execute DF_QCfax to email the query report to a valid email account.

  12. Verify the status of the queries in the sent report.

2.12. Module 11: Replying to EDC Queries, eSignatures

  1. Determine a count of outstanding/outstanding queries in Status View.

  2. Review outstanding queries in Queries View.

  3. Using EDC, locate and reply to outstanding clarification queries.

  4. Add an Electronic Signature (eSign) to a set of completed subject records.

2.13. Module 12: Re-submitting CRFs and Correcting Queries

  1. Submit PDF images to DFexplore.

  2. Verify that all CRFs have arrived successfully in Image view.

  3. Retrieve submitted CRFs using DFexplore Image View.

  4. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.

  5. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.

  6. Enter Form 4, Subject 99004.

  7. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.

  8. Select and resolve a query in a field that has multiple queries.

  9. Review and approve a pending query reply for Form 1 for Subject 99002.

  10. Review, correct and approve a pending query reply for Form 1, Subject 99007.

  11. Confirm query resolution by examining the database status.

2.14. Module 13: Data Export and DFsas

  1. Export date values from the database in calender format and save the exported data to a file on the local computer.

  2. Export date values from the database and save the exported data to a file on the local computer.

  3. Examining data values according to user-specified criteria.

  4. Query the database for specific data values.

  5. Create a DFsas job file according to user-specified criteria.

  6. Create a SAS job file and data files using the DFsas job file criteria.

  7. Compare the contents of SAS data files with the actual data in the database.

2.15. Module 14: PDF File Creation

  1. Retrieving existing data according to user-specified criteria.

  2. Saving DFexplore data to a standard PDF document.

  3. Viewing a standard PDF data file using a PDF viewer application.

  4. Saving DFexplore data to an encrypted bookmarked PDF file.

  5. Open and view an encrypted bookmarked PDF file using a PDF viewer application.

  6. Create a complete subject package PDF file that includes data records, CRF images and an audit trail.

  7. Open and view a PDF subject package using a PDF viewer application.

2.16. Module 15: eCRF Creation for DFdiscover

  1. eCRF creation in DFsetup.

  2. eCRF background color preferences.

  3. Entering eCRF data in DFexplore.

2.17. Module 16: DFweb Data Entry

  1. Modify valid1 user permissions for DFweb entry.

  2. Verify DFweb version information, logging into DFweb and DFweb site certificate.

  3. Copying URL and changing user passwords.

  4. Creating a new subject, entering subject data.

  5. Adding, modifying and resolving queries.

  6. Adding, reviewing and downloading subject documents.

2.18. Module 17: DFcollect Mobile Data Collection

  1. Modify valid1 user permissions for DFcollect entry.

  2. Installation, App preferences and initial DFcollect login.

  3. Online data record creation.

  4. Download subject data for offline use.

  5. Create data records in offline mode, query resolution and adding reasons for data values.

  6. Sync data collected offline to your DFdiscover server.

  7. Clearing DFcollect cache.

  8. Adding, reviewing and downloading subject documents.

  9. Confirming data sent to the server using DFexplore.

2.19. Module 18: User-defined Property Tags

  1. Defining User-defined property tags in DFsetup.

  2. Adding Global User-defined property values.

  3. Adding Plate, Module and Variable level User-defined property values

  4. Exporting User-defined property tags in DFsetup.

  5. Edit checks execution of User-defined property tags.

  6. Creating subject data lists and exporting data views.

  7. DFexplore Database Definition Report exporting.

2.20. Signature and Date

Completed By (print name) 
Title 
Completed By (signature) 
Signature Date 

Chapter 3. Discrepancy Report

Discrepancy Reports should be completed whenever an unexpected result is obtained during the execution of the Acceptance Test Study. A discrepancy may be a difference in the actual result from the expected result, a system malfunction, an error in the Acceptance Test Study documentation, or an error in the Acceptance Test Study Control Panel or study setup. Complete one report per incident.

  • Give each report a unique Discrepancy Report Number. You may want to simply sequentially number the reports starting at 1, or you may want to use a more elaborate numbering system.

  • Record the particulars about your system. This includes the DFdiscover Release being tested at your site (e.g., 5.2.0 ), the Server Operating System and Version.

  • Record the Test Number that you were executing when the problem occurred. This is the number that identifies the current step in the plan (e.g., 6.4.5).

  • Describe, as accurately and as completely as possible,the problem that occurred. Include any error messages that appeared on screen. Can someone who was not sitting at the computer when the problem occurred understand your description?

  • If you were able to work around the problem and continue, describe the workaround that was used.

  • Record your name, title, signature and the current date on the report. Sign it.

  • If the discrepancy appears to be an error that needs resolution by DF/Net Software ULC, forward the report to DF/Net Software ULC via email to . Record that a copy of the report has been sent to DF/Net Software ULC and the date that it was sent.

  • If a resolution to the problem becomes available, either internally, or from DF/Net Software ULC, provide a description of that resolution and the date.

Discrepancy Report NumberDFdiscover Release
Server Operating System and Version

3.1. Problem

 

3.2. Immediate Workaround

 

3.3. Problem Resolution

 

3.4. Signature and Date

Completed By (print name) 
Title 
Completed By (signature) 
Signature Date 

Part II. Modules

Table of Contents

1. Module 1: Installation and Initialization
1.1. Tests & Requirements
1.2. Confirm version information can be obtained for DFdiscover.
1.3. Obtain super-user privileges and remove older Acceptance Test Study, if one exists.
1.4. Install the Acceptance Test Study.
1.5. Define Acceptance Test Study to the DFdiscover server.
1.6. Create a role and permissions for valid1.
1.7. Create a DFdiscover account for valid1.
1.8. Create a role and permissions for datafax.
1.9. Enable high definition imaging.
1.10. Start the Acceptance Test Study Control Panel application.
2. Module 2: DFexplore Client Applications
2.1. Tests & Requirements
2.2. Begin Module 2.
2.3. Send PDF images to DFexplore.
2.4. Verify the on-line user documentation. Open the Image Router and verify the appearance of the Welcome Image.
2.5. Open the Acceptance Test Study and verify the standard DFexplore views.
2.6. Start DFsetup and verify version information.
2.7. Login and verify the on-line setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.
2.8. End Module 2.
3. Module 3: Study Setup
3.1. Tests & Requirements
3.2. Begin Module 3.
3.3. Permitted users can gain exclusive access to DFsetup to modify a study setup.
3.4. Define Global study preferences and apply settings to DFsetup.
3.5. Create and modify a new style (Comment).
3.6. Create and modify a new module (Death).
3.7. Assign Field definitions to a newly created module.
3.8. Assign a module's field definitions to a plate.
3.9. Correct field ordering on the current plate to set fixed field traversal order for data entry.
3.10. Use copy and paste to create repeating module and field references on a plate.
3.11. Create user-defined query category codes.
3.12. Submit a copy of the newly setup Plate 11 into the study database and retrieve the page in DFexplore Image View.
3.13. Enter and save all data on the submitted plate 11.
3.14. End Module 3.
4. Module 4: EDC Data Entry
4.1. Tests & Requirements
4.2. Begin Module 4.
4.3. Login to DFexplore and inspect the list of sites, subjects and visits in the record list window.
4.4. Enter and save new data using EDC data entry for Subject 99007.
4.5. Add reasons to explain entered data values.
4.6. Enter and save Plate 3, Subject 99007 as a pending record.
4.7. Mark and save unavailable data as missed. Unmark available data as missed.
4.8. Retrieve and modify existing data using a predefined task and save modifications to the database.
4.9. Confirm audit trail information for entered and modified data.
4.10. End Module 4.
5. Module 5: Image Data Entry
5.1. Tests & Requirements
5.2. Begin Module 5
5.3. Send PDF images to DFexplore.
5.4. Login to DFexplore and confirm the receipt of new pages in the Status View.
5.5. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.
5.6. Login to DFexplore and confirm receipt of the routed page in the Status View.
5.7. Retrieve new images in DFexplore Image View.
5.8. Enter Plate 1 (Form 1) for Subject 99002.
5.9. Enter Plate 2 (Form 2) for Subject 99002.
5.10. Enter Plate 3 (Form 3) for Subject 99002.
5.11. Enter Plate 4 (Form 4) for Subject 99002.
5.12. Compare the resolutions between Standard Definition (SD) version of an image and High Definition (HD) version of the same image.
5.13. Edit an existing query.
5.14. Delete an existing query.
5.15. Change data and record a reason for data change.
5.16. Batch validate all opened pages for Subject 99002 to level 2.
5.17. Confirm the status of entered pages in Status View.
5.18. End Module 5.
6. Module 6: User-Defined Query Category Types
6.1. Tests & Requirements
6.2. Begin Module 6.
6.3. Retrieve an existing data record in DFexplore.
6.4. Apply a user-defined Query Category query.
6.5. Add a reason for Data Value to explain entered data.
6.6. Edit an existing query.
6.7. Remove a user-defined Query Category that is used by an existing query.
6.8. Delete a user-defined Query Category query.
6.9. End Module 6.
7. Module 7: Multiple Queries Per Field
7.1. Tests & Requirements
7.2. Begin Module 7.
7.3. Submit PDF images to DFexplore.
7.4. Enable multiple queries per field in DFsetup.
7.5. Retrieve submitted CRF in DFexplore Image View.
7.6. Enter Plate 9 for Subject 99002.
7.7. Apply multiple queries to a field.
7.8. Select and edit an existing query in a field that has multiple queries.
7.9. Select and reply to an existing query in a field that has multiple queries.
7.10. Select and delete an existing query in a field that has multiple queries.
7.11. End Module 7
8. Module 8: Double Data Entry (DDE)
8.1. Tests & Requirements
8.2. Begin Module 8.
8.3. Retrieve a set of records for entry by Double (2nd pass) Data Entry (DDE).
8.4. Perform DDE such that discrepancies exist between the new DDE values and the original data values.
8.5. Programmed edit checks execute as expected during DDE.
8.6. Verify the audit trail of DDE data.
8.7. End Module 8
9. Module 9: Data Review
9.1. Tests & Requirements
9.2. Begin Module 9.
9.3. Retrieve all data for Site 99 that exists at level 3.
9.4. Review and approve a pending reason for data value, and approve a selected query in a field that has multiple queries.
9.5. Review and move approved reasons for data values to a higher workflow level, and review queries in a field that has multiple queries.
9.6. Data review and add a query to inconsistent data.
9.7. Review and complete pending data for Subject 99007.
9.8. Confirm audit trail information for reviewed and modified data.
9.9. Run batch edit checks to verify data integrity.
9.10. Use a data expression to retrieve specific subject information.
9.11. Use cross-plate data criteria to retrieve specific subject information.
9.12. End Module 9.
10. Module 10: External Query Reports
10.1. Tests & Requirements
10.2. Begin Module 10.
10.3. Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.
10.4. Run database integrity check report DF_XXkeys to export all key fields and visit dates from required plates in the database.
10.5. Use Data View to check and, if necessary correct, illegal visit dates by retrieving the problems keys identified by DF_XXkeys.
10.6. Execute DF_QCupdate to update the query database and lock all records for query report generation.
10.7. Execute DF_QCreports to create a standard, 3-part external query report for a study site.
10.8. Confirm the status of external queries following query report creation.
10.9. Execute DF_QCstatus to verify that a new query report was created by listing all reports in the QC/NEW directory.
10.10. Execute DF_QCview to display the newly created query report.
10.11. Execute DF_QCprint to print the query report from the QC/NEW directory.
10.12. Comparing several examples from the printed query report against their corresponding queries in the study database.
10.13. Execute DF_QCfax to email the query report to a valid email account.
10.14. Verify the status of the queries in the sent report.
10.15. End Module 10.
11. Module 11: Replying to EDC Queries, eSignatures
11.1. Tests & Requirements
11.2. Begin Module 11.
11.3. Determine a count of outstanding/outstanding queries in Status View.
11.4. Review outstanding queries in Queries View.
11.5. Using EDC, locate and reply to outstanding clarification queries.
11.6. Add an Electronic Signature (eSign) to a set of completed subject records.
11.7. End Module 11.
12. Module 12: Re-submitting CRFs and Correcting Queries
12.1. Tests & Requirements
12.2. Begin Module 12.
12.3. Submit PDF images to DFexplore.
12.4. Verify that all CRFs have arrived successfully in Image view.
12.5. Retrieve submitted CRFs using DFexplore Image View.
12.6. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.
12.7. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.
12.8. Enter Form 4, Subject 99004.
12.9. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.
12.10. Select and resolve a query in a field that has multiple queries.
12.11. Review and approve a pending query reply for Form 1 for Subject 99002.
12.12. Review, correct and approve a pending query reply for Form 1, Subject 99007.
12.13. Confirm query resolution by examining the database status.
12.14. End Module 12.
13. Module 13: Data Export and DFsas
13.1. Tests & Requirements
13.2. Begin Module 13.
13.3. Export date values from the database in calender format and save the exported data to a file on the local computer.
13.4. Export date values from the database and save the exported data to a file on the local computer.
13.5. Examining data values according to user-specified criteria.
13.6. Query the database for specific data values.
13.7. Create a DFsas job file according to user-specified criteria.
13.8. Create a SAS job file and data files using the DFsas job file criteria.
13.9. Compare the contents of SAS data files with the actual data in the database.
13.10. End Module 13.
14. Module 14: PDF File Creation
14.1. Tests & Requirements
14.2. Begin Module 14.
14.3. Retrieving existing data according to user-specified criteria.
14.4. Saving DFexplore data to a standard PDF document.
14.5. Viewing a standard PDF data file using a PDF viewer application.
14.6. Saving DFexplore data to an encrypted bookmarked PDF file.
14.7. Open and view an encrypted bookmarked PDF file using a PDF viewer application.
14.8. Create a complete subject package PDF file that includes data records, CRF images and an audit trail.
14.9. Open and view a PDF subject package using a PDF viewer application.
14.10. End Module 14.
15. Module 15: eCRF Creation for DFdiscover
15.1. Tests & Requirements
15.2. Introduction
15.3. Begin Module 15.
15.4. eCRF creation in DFsetup.
15.5. eCRF background color preferences.
15.6. Entering eCRF data in DFexplore.
15.7. End Module 15.
16. Module 16: DFweb Data Entry
16.1. Introduction
16.2. Tests & Requirements
16.3. Begin Module 16.
16.4. Modify valid1 user permissions for DFweb entry.
16.5. Verify DFweb version information, logging into DFweb and DFweb site certificate.
16.6. Copying URL and changing user passwords.
16.7. Creating a new subject, entering subject data.
16.8. Adding, modifying and resolving queries.
16.9. Adding, reviewing and downloading subject documents.
16.10. End Module 16.
17. Module 17: DFcollect Mobile Data Collection
17.1. Introduction
17.2. Tests & Requirements
17.3. Begin Module 17.
17.4. Modify valid1 user permissions for DFcollect entry.
17.5. Installation, App preferences and initial DFcollect login.
17.6. Online data record creation.
17.7. Download subject data for offline use.
17.8. Create data records in offline mode, query resolution and adding reasons for data values.
17.9. Sync data collected offline to your DFdiscover server.
17.10. Clearing DFcollect cache.
17.11. Adding, reviewing and downloading subject documents.
17.12. Confirming data sent to the server using DFexplore.
17.13. End Module 17.
18. Module 18: User-defined Property Tags
18.1. Tests & Requirements
18.2. Begin Module 18.
18.3. Defining User-defined property tags in DFsetup.
18.4. Adding Global User-defined property values.
18.5. Adding Plate, Module and Variable level User-defined property values
18.6. Exporting User-defined property tags in DFsetup.
18.7. Edit checks execution of User-defined property tags.
18.8. Creating subject data lists and exporting data views.
18.9. DFexplore Database Definition Report exporting.
18.10. End Module 18.

Chapter 1. Module 1: Installation and Initialization

1.1. Tests & Requirements

  1. Confirm version information can be obtained for DFdiscover.

  2. Obtain super-user privileges and remove older Acceptance Test Study, if one exists.

  3. Install the Acceptance Test Study.

  4. Define Acceptance Test Study to the DFdiscover server.

  5. Create a role and permissions for valid1.

  6. Create a DFdiscover account for valid1.

  7. Create a role and permissions for datafax.

  8. Enable high definition imaging.

  9. Start the Acceptance Test Study Control Panel application.

Estimate of Time Required: 30 Minutes

1.2. Confirm version information can be obtained for DFdiscover.

  1. Confirm the Acceptance Test Kit is installed on the following Linux operating system:

    • Red Hat / CentOS

    • SUSE

  2. Confirm DFdiscover version information by starting DFexplore.

  3. In the login dialog, click About. Confirm that the version information in the dialog matches the installed software Version 5.2.0.

  4. If the DFexplore release is not DFdiscover 2019 Version 5.2.0, you must stop at this point. The Acceptance Test Kit is specifically designed for release DFdiscover 2019 Version 5.2.0.

  5. Exit DFexplore.

1.3. Obtain super-user privileges and remove older Acceptance Test Study, if one exists.

[Note]Note

This step is required only if 254 Acceptance Test Study already exists on your DFdiscover server. If it does not currently exist on your DFdiscover server, skip this section and continue with Section 1.4, “Install the Acceptance Test Study. ”. If an earlier version does exist on your server, delete it prior to installation by following these steps.

  1. Start DFadmin. Login to your DFdiscover Server as datafax.

  2. Specify a Username of datafax, and the assigned user password in the Password field. Click Login to complete login and continue.

    Click Status Tab. This illustration shows that the 254 Acceptance Test Study is already defined.

    The list of studies defined on your DFdiscover Server will be displayed in the studies list.

  3. Select the entry for 254 Acceptance Test Study from the list of studies. Select Action > Disable study. In the confirmation dialog, enter the text Study Removal.

  4. Click Disable to disable the Acceptance Test Kit.

  5. Click Studies tab. Select the entry for 254 Acceptance Test Study if it is not already highlighted. Click Delete.

    From the 3 delete options, choose Remove Study from DFdiscover.

  6. Click Delete in the confirmation dialog to continue with the delete.

  7. In the Remove Study dialog, de-select (disable) Archive Study Permissions and click Continue.

  8. To confirm, enter the password for datafax and click OK. Close the study removal confirmation dialog by clicking OK.

1.4. Install the Acceptance Test Study.

[Note]Note

Existing Acceptance Test Kit directories, val254 and .val254_states, must be removed prior to installation of the DFdiscover 2019 Version 5.2.0 Acceptance Test Kit. This is because the study directory structure and/or base states have changed with DFdiscover 2019 Version 5.2.0.

If the directories are present at this time, installation of the DFdiscover 2019 Version 5.2.0 Acceptance Test Kit will create a TAR file of the existing installation and re-install the updated DFdiscover 2019 Version 5.2.0 val254 and .val254_states directories.

  • The DFATK-5.2-0.x86_64.rpm file can be found on www.dfnetresearch.com in the Support section. After downloading the DFATK-5.2-0.x86_64.rpm execute the installation using rpm on OpenSUSE & RHEL operating systems. The installation defaults to the /opt/studies directory, this can be changed using the rpm --prefix=NEWPATH flag.

    • New installations using rpm, which will automatically download and install any dependencies required:

      # rpm -ivh DFATK-5.2-0.x86_64.rpm

      OR, specify an alternative installation location:

      # rpm -ivh --prefix=NEWPATH DFATK-5.2-0.x86_64.rpm

    • Upgrade installations using rpm, which will automatically download and install any dependencies required:

      # rpm -U DFATK-5.2-0.x86_64.rpm

      OR, specify an alternative installation location:

      # rpm -U --prefix=NEWPATH DFATK-5.2-0.x86_64.rpm

      [Note]Note

      Use of rpm -U --prefix=NEWPATH does not alter current definitions of DFstudyspaces.db or DFstudies.db. These files must be manually updated to inlcude the specified prefix pathing.

    • Confirm the presence of 254 Acceptance Test Study with the command:# ls -d /opt/studies/val254

    • As root open DFserveradmin to the Study Spaces view. If not already present, add a Study Space for the directory /opt/studies. Name the Study Space opt_studies. Check (enable) the Active box and apply the entry.

1.5. Define Acceptance Test Study to the DFdiscover server.

  1. Return to DFadmin, select the Studies tab. Add a definition for 254 Acceptance Test Study. Click New and complete the dialog with the following values:

    • Study Number: 254

    • Study Name: Acceptance Test Study

    • Study Space: opt_studies (or the name of the Study Space for the /opt/studies directory)

    • Study Folder: val254

    • Select Restore previous Study at this location

    [Note]Note

    The name of your Study Space may differ from that shown here if the Study Space is something other than opt_studies on your DFdiscover server.

  2. Click OK to confirm the action and add an entry for 254 Acceptance Test Study to the list of studies.

  3. Verify configuration information and set the Preset Printer. Select the newly added 254 Acceptance Test Study entry from the list of studies. Click Configurations tab and enter the name of a networked printer in the Preset Printer field.

  4. Choose All minor versions supported from the Version Strict drop-down.

  5. Select File > Save or clicking Save to save the configuration information.

1.6. Create a role and permissions for valid1.

  1. Create a Role for user valid1. Begin this task by clicking the Roles tab.

    [Note]Note

    If the role already exists, confirm the permissions and settings described in Step 2 to Step 8 and make changes where necessary.

  2. In the list of studies, locate and choose 254 Acceptance Test Study. Click New to add a new user role. In the confirmation dialog, enter the role name.

  3. Click Create in the New Role dialog to apply the role name.

  4. In the Description field enter: Levels 0-4, data entry and meta data.

  5. Click Tools & Reports tab. Check (enable) each of the following: DFexplore, Server & DFsetup, DFdiscover Reports, and Study Reports.

  6. Click Auto Logout tab. If not already checked (enabled), check Inherit from Study to override the default Auto Logout setting with the study setting.

  7. Click Permissions tab. This view is for the definition of data type permissions associated with the role.

  8. Set data permissions with the following settings:

    • Visits = ALL

    • Plates = ALL

    • Levels = 0-4

    • Check (enable) Show Hidden Fields

    • Check (enable) Show Int. Queries

    • Modify Levels = 0-4

    • Write = 0-4

    • Data Check (enable) = CMDL (Create, Modify, Delete, Missed), but not P (Password).

    • Queries Check (enable) = CMDAR (Create, Modify, Delete, Approve, Reject)

    • Reasons Check (enable) = CMDA (Create, Modify, Delete, Approve)

  9. Select File > Save or by clicking Save to save Tool & Reports, Auto Logout and Permissions for role.

1.7. Create a DFdiscover account for valid1.

  1. Still as datafax and with the DFadmin application open, click Users tab to open the user definition window.

  2. Determine if user valid1 has already been defined. Review the list of users to determine if an entry exists for user valid1.

    [Note]Note

    If an entry for valid1 cannot be located in the list of users, complete Step 3 to Step 12 inclusive.

    [Note]Note

    If an entry for valid1 can be located in the list of users, complete Step 13 to Step 16 inclusive.

  3. Click New to add a DFdiscover account for user valid1. In the resulting dialog, enter the username valid1 as shown.

  4. Click Create to add valid1 to the list of users. An empty icon represents valid1, the status of valid1 is set to Inactive.

  5. Choose the valid1 entry from the list of users if it is not already highlighted. Click User Profile tab. Enter these settings:

    • Full Name = valid1

    • Affiliation = DF/Net Software ULC

    • Email = Your email address

    [Note]Note

    A valid email address is required to receive module specific PDF files if you have not specified a printer in the Master view.

  6. No further user profile information is needed. Select File > Save or by clicking Save.

  7. Set permissions for user valid1. With user valid1 still as the active user, click Permissions tab. Check (enable) Allow access to Image Router to grant permissions to the DFexplore Image Router.

  8. To assign a study to valid1, click the blank area below the Study heading. Select 254 Acceptance Test Study from the Study drop-down. Set:

    • Sites = All

    • Subjects = All

    • Role Name = valid1 permissions

  9. Select Active from the Status drop-down list to change the status from Inactive to Active for user valid1.

  10. Assign a DFdiscover password for valid1 by clicking New Password. Enter a password of your choice in place of the auto-generated system password.

    [Note]Note

    Remember the password assigned in this step as it is needed in future tests.

  11. Save all previously entered permissions, roles and password by selecting File > Save or by clicking Save.

  12. Skip Step 13 to Step 16 and go to Step 1.

  13. Locate and choose the entry for user valid1 in the list of users. Click Permissions tab and confirm the following settings. If any of the following permissions do not appear as shown below, set them now.

    • Allow access to Image Router box is checked (enabled)

    • 254 Acceptance Test Study is assigned to user valid1.

    • Sites = ALL

    • Subjects = ALL

    • Role Name = valid1 permissions

  14. Verify the status for valid1. If valid1 is set to Inactive, select Active from the Status drop-down list.

  15. Assign a DFdiscover password for valid1 by clicking New password. Enter a password of your choice in place of the auto-generated system password.

    [Note]Note

    Remember the password assigned in this test step as it is needed in future tests.

  16. Save all previously entered permissions, roles and password by selecting File > Save or by clicking Save.

1.8. Create a role and permissions for datafax.

User datafax is already defined on your DFdiscover installation, however, you must grant user datafax a role and permissions to be able to access 254 Acceptance Test Study.

  1. Click Users tab.

  2. Create a Role for user datafax. Begin this task by clicking the Roles tab.

  3. Within the list of studies, locate and choose the entry for 254 Acceptance Test Study. Click New to the right of the Roles list to add a new user role. In the resulting dialog, enter the role name datafax permissions.

  4. Click Create to create the new role datafax permissions.

  5. Define Tools & Reports permissions for the datafax permissions role. Highlight datafax permissions in the Roles list to make it the active role. Enter Full permissions in the Description field.

  6. Click Tools & Reports tab below the Description field. Check (enable) each of the following: DFexplore, Server & DFsetup, DFdiscover Reports, and Study Reports.

  7. Click Auto Logout tab. If not already enabled, check (enable) the Inherit from Study box to override the default Auto Logout settings with those of the ATK study.

  8. Click Permissions tab.

  9. Set data permissions as follows:

    • Visits = ALL

    • Plates = ALL

    • Levels = ALL

    • Check (enable) Show Hidden Fields

    • Check (enable) Show Int. Queries

    • Modify = 0-7

    • Write Levels = 0-7

    • Data = Check (enable) CMDL (Create, Modify, Delete, Missed), but not P (Password)

    • Queries = Check (enable) CMDAR (Create, Modify, Delete, Approve, Reject)

    • Reasons = Check (enable) CMDA (Create, Modify, Delete, Approve)

  10. Select File > Save or clicking Save to save Tool & Reports, Auto Logout and Permissions settings for role datafax permissions.

  11. Still as datafax and with the DFadmin application open, click Users tab to open the Users window.

  12. Set permissions for datafax. Click the entry for datafax from the list of users to make it active. Click Permissions tab. Check (enable) the Allow access to Image Router box to grant permissions to the DFdiscover Image Router.

  13. To assign a study to datafax, click the blank area below the Study heading. Select 254 Acceptance Test Study from the Study drop-down. Set:

    • Sites = All

    • Subjects = All

    • Role Name = datafax permissions

  14. Select File > Save or clicking Save to save the previously entered role and permissions for datafax.

1.9. Enable high definition imaging.

  1. To enable high definition imaging, click the Traffic tab. Within that view, click the Inbound tab to display the Inbound view.

  2. Check Enable High Definition Imaging. The Normal Colors checkbox is enabled by default. If it is not, enable it. Click Save to save the settings.

  3. Select File > Exit to close DFadmin.

1.10. Start the Acceptance Test Study Control Panel application.

  1. The remaining steps in this module require datafax privileges. Open the Acceptance Test Kit login dialog.

  2. In the login dialog, enter the name of the study server on which the Acceptance Test Kit has been installed. As the Acceptance Test Kit Control Panel must be run as datafax, the Username field cannot be edited. Enter the previously specified password for datafax and click Login.

  3. In the Control Panel, confirm that Module 1 Installation and Initialization is the current module and that its status is Not yet performed.

    Click End to complete Module 1.

Chapter 2. Module 2: DFexplore Client Applications

2.1. Tests & Requirements

  1. Verify the on-line user documentation. Open the Image Router and verify the appearance of the Welcome Image.

  2. Open the Acceptance Test Study and verify the standard DFexplore views.

  3. Start DFsetup and verify version information.

  4. Login and verify the on-line setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.

Estimate of Time Required: 20 minutes

2.2. Begin Module 2.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 2 followed by Begin to begin this module.

2.3. Send PDF images to DFexplore.

  1. Click Send Welcome Image to email a copy of Welcome_Fax.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the Welcome_Fax.pdf file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

  2. Start DFsend as described in Section 1.8, “How to start DFsend.

  3. Click Add. From the Select PDF Files file selection dialog, locate the previously saved Welcome_Fax.pdf file. Select the file, Click Open.

    [Note]Note

    Alternatively documents can also be added by dragging-and-dropping the desired PDF files from a local file folder directly into the list area.

  4. Click Send. In Verify Password dialog, enter valid1 in the Username field and the previously assigned password in the Password field. Click OK.

  5. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  6. Click Show Log to reveiw the DFsend transmission history to DFexplore.

  7. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

2.4. Verify the on-line user documentation. Open the Image Router and verify the appearance of the Welcome Image.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select Help > Topics to access the documentation. In the documentation window, confirm the documentation version number. Select File > Close to dismiss the documentation window.

  3. Select File > Close study to exit the study.

  4. In the DFexplore login dialog, Click Image Router to start the Image Router. Locate the Welcome image by selecting the page from the list of documents in the CRF ID panel.

    [Note]Note

    Any pages that have been received and which DFdiscover could not identify as CRFs for any of the studies registered at your site, will be found in the Image Router. The Welcome image is added during initialization of the module. If there are more pages than the Welcome image in your Image Router window, you may need to locate the Welcome image in the list of images in the CRF ID panel.

  5. Print the Welcome image from the Image Router by selecting Page > Print. Choose your locally installed printer, choose All for Page Range, and click Print.

  6. Delete the Welcome image from the Image Router by selecting Action > Discard. Click OK to confirm the discard action.

  7. Select File > Close Image Router to exit the Image Router.

    The study selection dialog is presented.

2.5. Open the Acceptance Test Study and verify the standard DFexplore views.

  1. In the study selection dialog, highlight the entry for 254 Acceptance Test Study. Click Continue.

    [Note]Note

    If user valid1 has only one study defined and Allow access to image router is not enabled within DFadmin the study selection dialog is not displayed.

    If this step is performed within 60 seconds of closing the Image Router window, the Username, Password and list of studies are still visible. If more than 60 seconds have elapsed, you will first need to re-enter the Password for valid1, and click Login to view the study selection dialog. Then highlight the entry for 254 Acceptance Test Study and click Continue to continue.

  2. Select File > Preferences. In the Preferences dialog, open each panel and set the options exactly as illustrated. When finished, click OK to save the settings and close the dialog.

  3. Select View > Image to make Image view the current view. Set Quantity = 25. Do not change any other settings in the Automatic Retrieval dialog and click OK to retrieve the new documents.

    [Note]Note

    The record retrieval dialog displays the last retrieval mode from the session preferences for each user on each computer. If valid1 previously used DFexplore in another mode, you may not see the Automatic Retrieval dialog that is illustrated. You may see a different record retrieval dialog. When this happens, click Cancel in that record retrieval dialog. Then select Select > Automatic Retrieval and, as necessary, correct the settings in the resulting dialog so that they match the illustration.

  4. Image view becomes the current view 12 new records are displayed in the record list panel, and the first record is highlighted. The main window displays the data record in the top pane and document image in the bottom pane.

  5. Select View > Data to change to Data view. In the confirmation dialog, click OK to release the set of image records.

  6. Double-click entry for Site 99 - Hospital #99 in the record list panel. The site opens to display the subject list. The subject list displays all enrolled subjects and the next 5 potential subjects for each site.

  7. Double-click entry for Subject 99004 to list all visits for that subject. Select Subject > Expand All Visits. In the record list panel, locate the 6: Form 6 entry belonging to the 30 : Study Termination assessment. Click it to make it the active page in the main data window.

  8. 6: Form 6 has been defined in the study setup with colored, multi-language backgrounds as well as the default black/white English background for the data entry screen. Select File > Preferences. In the Preferences dialog, change:

    • CRF Type from Default to Dutch

    Click OK to save the preferences and close the dialog. Confirm that the background CRF in the data window has refreshed to the Dutch version.

  9. Re-select File > Preferences. Change the Background Options choice for CRF Type from Dutch to Spanish. Click OK to apply the preferences and close the dialog.

  10. Re-select File > Preferences. Reset the Background Options for CRF Type to Default. Click OK to save the preferences and close the dialog.

  11. Double-click entry for 99001. This closes 99004 and opens the list of visits for 99001. Select Subject > Expand All Visits to open all visits and pages for subject 99001. In the record list panel, locate 1: Form 1 under 0 : Screening Visits. Click it to open the page in the main data window.

  12. Select View > Queries to switch to Queries View. Select Show > All Queries to display all queries for the current subject.

  13. Select View > Reasons to switch to Reasons View. Select Show > All Reasons.

  14. Select View > List to switch to List View. Confirm that the Plates & Metadata tab is highlighted at the top of the record list panel. Click 001 - Blood Pressure Screening Visits from the list of plates.

  15. Choose the Modules tab at the top of the list panel to display a list of all modules defined for the study. Click Demographics - Patient Demographics module.

  16. Select View > Batch Edits to switch to Batch Edits View.

  17. Select View > Reports to switch to Reports View. In the reports list panel, double-click DFdiscover Reports followed by Legacy Reports. Highlight the report DF_PTcrfs from the list of Legacy Reports.

  18. In the Specify field, enter the report option -i 99001. Click Run to run the report for subject 99001. Examine the output displayed in the output window.

  19. Select View > Status to switch to Status View.

    [Note]Note

    Any pages that have been received and which DFdiscover could not identify as study CRFs will be found in the Image Router. As a result, the number of Images awaiting review in Image Router may differ from what is shown here.

  20. Select View > Dashboard to display the Dashboard View. Click ..., select Record status tabular view and Record status chart. Click OK.

  21. Select View > Schedule to display the Schedule View. Click Refresh to display the scheduling information.

  22. Select File > Exit to exit DFexplore.

2.6. Start DFsetup and verify version information.

  1. Start DFsetup and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  2. In the login dialog, click About. Confirm that the version information in the dialog matches the installed software version.

2.7. Login and verify the on-line setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.

  1. Start DFsetup and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  2. In the studies selection dialog, highlight the entry for 254 Acceptance Test Study. Click Continue to continue.

  3. Choose View Only and click OK to continue. The main DFsetup window opens.

  4. Select Help > Topics to access the documentation. In the documentation window, confirm the documentation version number. Select File > Close to dismiss the documentation window.

  5. Select any plate entry in the Plates-Modules-Fields list panel to make that plate the active plate. The main window is refreshed with the CRF view of the plate definition, which includes widgets for all modules and fields. Click any field widget on the current plate to make that field the active field.

    [Note]Note

    DFsetup remembers the last active plate from your previous DFsetup session so your main DFsetup window may display a different plate as the active plate.

  6. Select the 2 - Patient Entry Form entry from the list panel to make plate 2 the active plate. Click Field List to replace the CRF view with a listing of all plate 2 fields and their properties. Click CRF to return to the CRF view of plate 2.

  7. Select the entry for 6 - Patient Evaluation Report from the list panel to make plate 6 the active plate. Examine the CRF List panel displayed in the bottom-left of the screen. Each entry represents a unique multi-language color background associated with plate 6. This study database has been defined to include colored, multi-language CRF backgrounds for plate 6, with the default background being black/white English. The default English background and some of these multi-language backgrounds were accessed previously in Section 2.5, “Open the Acceptance Test Study and verify the standard DFexplore views.”.

  8. From the CRF List panel, choose the entry 30 Dutch.

  9. Select File > Preferences. In the Preferences dialog, choose Color for Background Color. Click OK to close the Preferences dialog.

  10. From the CRF List panel, choose the entry 30 Spanish.

  11. Return to the default (English) CRF background for plate 6 by choosing the DEFAULT in the CRF List panel.

  12. Select View > Sites to open the Sites editor. Review the contents.

  13. Select View > Visit Map to open the Visit Map editor. Visually confirm that the expected contents are displayed. Click Done to close the editor.

  14. Select File > Exit to close DFsetup.

2.8. End Module 2.

  • Return to the DFATK application. Click End to confirm successful completion of Module 2.

Chapter 3. Module 3: Study Setup

3.1. Tests & Requirements

  1. Permitted users can gain exclusive access to DFsetup to modify a study setup.

  2. Define Global study preferences and apply settings to DFsetup.

  3. Create and modify a new style (Comment).

  4. Create and modify a new module (Death).

  5. Assign Field definitions to a newly created module.

  6. Assign a module's field definitions to a plate.

  7. Correct field ordering on the current plate to set fixed field traversal order for data entry.

  8. Use copy and paste to create repeating module and field references on a plate.

  9. Create user-defined query category codes.

  10. Submit a copy of the newly setup Plate 11 into the study database and retrieve the page in DFexplore Image View.

  11. Enter and save all data on the submitted plate 11.

Estimate of Time Required: 20 Minutes

3.2. Begin Module 3.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 3 followed by Begin to begin this module.

3.3.  Permitted users can gain exclusive access to DFsetup to modify a study setup.

  1. This module requires user valid1 to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

  2. Start DFsetup and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  3. Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

  4. Select File > Preferences to open the Preferences dialog. Set:

    • Exit after __ minutes of inactivity = 5

    • Background Color = Color

    Click OK to save and close the dialog.

3.4. Define Global study preferences and apply settings to DFsetup.

  1. Select Study > Global Settings to open the Global Settings dialog. Click Global tab. Confirm that:

    • Study launched in the year = 1990

    • Reasons for data change are required = per field

    • Show next __ New Subject binders = 5

    • Check (enable) Enable New Subject creation

    • Uncheck (disable) Run Edit checks in View mode

    If these options are not set this way, modify them now and click Apply.

  2. Click Help enter Welcome to the Acceptance Test Study. For assistance please contact 1-XXX-XXX-XXXX.. Click Apply.

  3. Click Fields tab, and set:

    • Descriptions = 40 characters

    • Start year (for two digit years) = 1920

    • Imputation (for partial dates) = Never

    • Check (enable) Auto Generate Help

    • Uncheck (disable) Field Name must be unique across all module definitions

    • Do not edit Fill Color

  4. Click Levels tab. Confirm that the workflow labels of Level 0, Level 1, and through to Level 7 are used.

  5. Click Guides tab. Confirm/change:

    • Check (enable) Enable Snap

    • Check (enable) Display CRF

    • Check (enable) Display Fields

    • Set Maximum Box Height = 25

    • No changes are required to Colors Fields or Foreground

  6. Click User-defined tab.

  7. Click OK to save changes and exit the dialog.

3.5. Create and modify a new style (Comment).

  1. Select View > Styles from the menubar.

    [Note]Note

    The style names and information appearing in your Styles dialog may be different from those shown here. You should see the standard DFdiscover Simple styles.

  2. Within the DFsetup-Styles dialog, locate the style name SimpleString. Click SimpleString to select it as the current style. Click Clone to duplicate this style.

  3. Provide a Style name of Comment in the Style dialog and click OK.

  4. Click new style of Comment to make it active, confirm the Style Properties Basic tab displays the style properties as shown.

  5. Click Detail tab, Change the Store property from 1 to 200. Check (enable) the to the left of the Store property to lock this setting in the Comment style. Click Apply to apply the modifications. Click Done to close the Style Properties dialog.

3.6. Create and modify a new module (Death).

  1. Choose 10 - Death Report entry from the Plates-Modules-Fields list panel to make plate 10 the active plate. Select View > Modules to open the module definition dialog.

  2. Click Module options New.

  3. Enter a name of Death in the Add Module dialog. Click OK to save.

  4. With the Death module selected as the active module, confirm that the Name Death appears in the Module Properties window. In the Description field, enter Death Report as shown below. Click Apply.

3.7. Assign Field definitions to a newly created module.

  1. Choose Death module defined in Section 3.6, “Create and modify a new module (Death).” to make it the active module. Click Field options New.

  2. To create a field definition for “Cause of death”, choose Comment from the Style pull-down list, click OK.

  3. Enter the name DEATH for the Field Name: and click OK.

  4. Within the Field Properties, enter a Description of Cause of Death?. Click Apply.

  5. Click Field options New. In the resulting New Field Style dialog, choose S99 NO-YES from the Styles pull-down list. Click OK.

  6. Enter the name AUTOPSY for the Field Name: and click OK.

  7. Within the Field Properties, enter a Description of Was an autopsy performed?. Click Apply.

  8. Click Done.

3.8.  Assign a module's field definitions to a plate.

  1. Still with 10 - Death Report as the active plate, create the field references (layouts) for the Cause of death and autopsy fields defined in Section 3.7, “Assign Field definitions to a newly created module.”. First add the Death module to plate 10-Death Report by clicking Add from the Module options. Locate then choose Death module from the list of modules.

  2. Click OK to add the Death module to plate 10-Death Report.

  3. Click the left of the Death [1] module entry in the Plates-Modules-Fields list to show all field definitions within the Death [1] module.

  4. Create a field reference for the Cause of Death. Using the mouse, select Click the leftmost end of the second longest lines on the plate background. Holding down the left mousebutton and Control, drag up and across to the rightmost end of the line. Release the mousebutton to create a string field widget.

  5. Select the DEATH field in the Plates-Modules-Fields listing to assign a field definition.

  6. Create a field reference for the Was an autopsy performed? field. Using the mouse, Click the middle of the No box on the plate background. Next click the middle of the Yes box on the plate background. This defines the position of each response option for the AUTOPSY field.

  7. Select the AUTOPSY field in the Plates-Modules-Fields listing to assign a field definition.

3.9. Correct field ordering on the current plate to set fixed field traversal order for data entry.

  1. All fields are now defined on plate 10 - Death Report. Select Field > Order. In the dialog, sort the fields as shown below, by using the arrow buttons.

  2. Click OK to apply the selected field order.

  3. Click to the left of the entry 10-Death Report in the Plates-Modules-Fields list to collapse all plate 10 - Death Report modules.

3.10. Use copy and paste to create repeating module and field references on a plate.

  1. Click 11 - Weekly Patient Diary to make it the active plate. Scroll to view all module and field references on the plate.

  2. Click to the left of the entry 11-Weekly Patient Diary to expand the list of modules defined on the current plate. Choose Diary[6] from the list.

  3. Click Copy from the Module options.

  4. Click Paste from the Module options.

  5. In the Paste-Module-fields dialog specify the substitution shown below in order to modify the Alias and Description fields.

  6. Click OK in the Paste-Module-fields dialog to perform the paste operation.

  7. With the block of fields still highlighted, use the mouse to drag the block of field reference widgets and position them over top of their respective field outlines on the plate background. Click anywhere on the plate background to release the pasted block.

  8. One by one select each Diary[7] field reference widget. Examine the Field Properties window for each and confirm that the Alias and Description properties contain the correct substitution character of 7.

3.11. Create user-defined query category codes.

  1. Select View > Query Category Map.

  2. Click Add. The Code field is auto-filled with a value of 30. Press Tab to advance to the Label field. Enter Test for the Label field. Select Yes from the Auto-Resolve drop-down. Set Sort Order to 5.

  3. Click Add. The Code field is auto-filled with a value of 31. Without altering the code number, enter Monitor for the Label field. Select Yes from the Auto-Resolve drop-down. Set Sort Order to 3.

  4. Click Add. Without altering the code number, enter Clinical QC for the Label field. Select No from the Auto-Resolve drop-down. Set Sort Order to 10.

  5. Click Save > Done to close the dialog.

  6. Select File > Save [Required] from the menubar to save all modifications to the 254 Acceptance Test Study setup. Click Save in the warning dialog. Select File > Exit to close DFsetup.

3.12. Submit a copy of the newly setup Plate 11 into the study database and retrieve the page in DFexplore Image View.

  1. In order to complete the remainder of Module 3, the Control Panel is needed. Start the Control Panel as datafax as described in Module 1 (Installation & Initialization).

  2. Click Send ID 99006 to email a copy of ID99006.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the ID99006.pdf file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

  3. Start DFsend as described in Section 1.8, “How to start DFsend.

  4. Click Add. From the Select PDF Files file selection dialog, locate the previously saved ID99006.pdf file. Select the file, Click Open.

    [Note]Note

    Alternatively documents can also be added by dragging-and-dropping the desired PDF files from a local file folder directly into the list area.

  5. Click Send. In Verify Password dialog, enter valid1 in the Username field and the previously assigned password in the Password field. Click OK.

  6. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  7. Click Show Log to reveiw the DFsend transmission history to DFexplore.

  8. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

  9. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  10. Select View > Image.

  11. Do not change any settings in the Automatic Retrieval dialog, click OK to retrieve the image.

  12. Select Plate > Show Field Properties to display a listing of properties for all fields on the current page. Locate field numbers 46 to 51 that were created in Section 3.10, “Use copy and paste to create repeating module and field references on a plate.”. Verify the settings click OK.

3.13. Enter and save all data on the submitted plate 11.

  1. Upon retrieval of plate 11-Weekly Patient Diary, the cursor is on the Study Week # field. Enter the Study Week # value as it appears on the CRF image. Note that a prefix of 2 is hardcoded in the Study Week # field so that the resulting value will appear as 201. Press Tab to advance to the Patient Number field.

  2. Enter the Patient Number as it appears on the CRF image. Press Tab move to the Patient Initials field. Enter ANK as per the CRF image and press Tab to advance to the next field.

  3. Starting with the Check this box... field, enter all data for 11-Weekly Diary Report as it appears on the CRF image in the lower half of the split screen window. Press Tab to move from field to field until field 6. My blood pressure today is the current field. Leave the field blank as per the CRF image and press Tab. The Add Query dialog is presented.

  4. Click Cancel in the Add Query dialog to close the dialog. The 2nd blood pressure field (diastolic) gets the focus. Leave the field blank as per the CRF image and Tab off the field. Again, click Cancel in the resulting Add Query dialog.

  5. Continue to enter the remaining fields on Plate 11-Weekly Patient Diary as per the CRF image. Once a value has been entered in the last VAS field (7. My energy level today), press Tab this makes the save buttons active at the bottom of the data record.

    [Note]Note

    During document submission, the ICR may fail on one or more of the fields on the Plate 11-Weekly Patient Diary page. You will need to enter values into those fields that have been missed or misread by the ICR. To correct VAS scales, make the desired VAS scale the current field on the data record. Locate the corresponding VAS scale on the CRF image. Using the left mouse button, select the leftmost end of the scale, followed by the intersection point, and then the rightmost end of the scale on the CRF image.

  6. With the focus on the save buttons, click Final to save the record to the database with the status Final.

  7. Select File > Exit to close DFexplore

3.14. End Module 3.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click End to confirm successful completion of Module 3.

Chapter 4. Module 4: EDC Data Entry

4.1. Tests & Requirements

  1. Login to DFexplore and the Acceptance Test Study and confirm the list of sites, subjects and assessments in the record list window.

  2. Enter and save new data using EDC data entry for Subject 99007.

  3. Add reasons to explain entered data values.

  4. Enter and save Plate 3, Subject 99007 as a pending record.

  5. Mark and save unavailable data as missed. Unmark available data as missed.

  6. Retrieve and modify existing data using a predefined task and save modifications to the database.

  7. Confirm audit trail information for entered and modified data.

Estimate of Time Required: 20 minutes

4.2. Begin Module 4.

Every module uses DFATK and must be run as datafax.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 4 followed by Begin to begin this module.

  3. Click Send ID 99007 to email a copy of ID99007_module4.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

    Wait 2-3 minutes prior to proceeding to DFexplore.

4.3. Login to DFexplore and inspect the list of sites, subjects and visits in the record list window.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Confirm that one site folder at a time can be opened/expanded to display a list of available subjects. In the record list panel, double-click Site 20 - Hospital #2, followed by Site 99 - Hospital #99.

  3. In the record list panel, double-click entry for Subject 99001 to select and open the subject binder. A list of available visits is displayed.

  4. Double-click entry for the highlighted 1 : Baseline visit to display the list of pages belonging to the visit.

  5. Close the subject binder for Subject 99001 by double-clicking Site 99 - Hospital #99 in the record list panel.

4.4. Enter and save new data using EDC data entry for Subject 99007.

  1. Using the paper CRFs that were printed or emailed at the beginning of this module (Step 2). Select Select > Change Mode & Level to set the working mode and data entry level. In the dialog, set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check Enable edit checks

    Click OK.

  2. Double-click Site 99 - Hospital #99 entry in the record list panel. Double-click Subject 99007.

  3. Double-click the 0 : Screening Visits entry to display all pages belonging to the visit.

  4. The 1 : Form 1 becomes the active page. The data window redraws with the plate background and related data entry fields.

  5. Click anywhere on the plate background - this moves the mouse and keyboard focus to the data window.

  6. Beginning at the Patient Number field, press Tab to advance to the Patient Initials. Enter the initials as they appear on the printed CRF. Press Tab to advance to the next field.

  7. Continuing from the Age field, press Tab to advance through the fields individually. Enter all remaining data as it appears on the printed CRF. Although leading zeros may not always appear on the paper CRF, be sure to enter leading zeros where necessary. After entering the Eligibility Criteria #6, press Tab to make the save buttons active.

  8. As no data problems exist on the entered page, the page can be saved to the database with a Final status. Click Final.

4.5. Add reasons to explain entered data values.

  1. To open a new visit for Subject 99007, double-click the entry labeled 1 : Baseline in the record list panel.

  2. Click anywhere on the plate background - this moves the mouse and keyboard focus to the data window.

  3. With Patient Number as the active field, attempt to edit the pre-filled value, note that this is not possible. Press Tab to advance to Patient Initials. The SetInit edit check executes upon entry to the field. If the initials are available on the 1 : Form 1 (previously entered), they are brought forward and populate the Patient Initials field.

  4. Press Tab to advance through each field and enter the data as it appears on the printed CRF, up to and including Weight (lbs). Press Tab to exit the Weight (lbs) field and execute the WeightEquiv edit check. The WeightEquiv edit check calculates and enters the equivalent value in the blank Weight (kg) field.

  5. The HeightEquiv edit check is similar to the WeightEquiv edit check. If only one of the two height values are entered, the edit check calculates and enters the equivalent value for the blank field. Press Tab to exit the Height (in) field and enter the value as it appears on the printed CRF (including leading zeros). Press Tab to exit the field.

  6. Enter all remaining data on the page as it appears on the printed CRF, up to and including the Pulse field. Press Tab to advance to the Smoking Status field.

  7. Select Field > Add Reason For Data Value or click in the Reason for Data Value window. In the resulting dialog, choose Approved from the pull-down list.

  8. Enter the text Smoking Status data will be provided once contact has been made with the patient. for the Reason property. Click OK, press Tab to advance to the Exercise field.

  9. Select Field > Add Reason For Data Value or click in the Reason for Data Value window. Choose Pending from the pull-down list.

  10. Enter the text Exercise data will be provided once contact has been made with patient. for the Reason property. Click OK, press Tab to advance to the Date of First Study Follow-up Visit field.

  11. Enter the Date of First Study Follow-up Visit and press Tab to advance to the save field. Verify that the Final is highlighted. Do not save the page with this status as the Smoking Status and Exercise fields have yet to be completed. Click Pending.

4.6. Enter and save Plate 3, Subject 99007 as a pending record.

  1. Subject 99007 3 : Form 3 becomes the current record. Click anywhere on the page background to make the fields active for entry.

  2. Starting at the Patient Number field, press Tab to advance to Patient Initials field. The SetInit edit check executes upon entry to the field.

  3. Continuing at Patient Initials, press Tab to advance through each field and enter the data as it appears on the printed CRF. The medical conditions that appear pre-printed on the CRF page have been defined as constant values in the study setup. As a result, these fields cannot be edited. Press Tab to advance to the save buttons. As data for Major Surgery is not yet complete, click Pending to save the page with status Pending.

4.7. Mark and save unavailable data as missed. Unmark available data as missed.

  1. The Baseline 4 : Form 4, Pg 1 is the active page. As no data is available for this page, select Plate > Set Page Missed....

  2. In the dialog, choose Data not available value from the Reason pull-down list. Enter Medication information is missing from patient's chart. as the Detail.

  3. Click OK to register the page as missed.

  4. Double-click Subject 99005 in the record list. From the now open list of visits for that subject, double-click the 1 : Baseline visit.

  5. All pages for that assessment are displayed.

  6. Choose 3 : Form 3. Select Plate > Unset Page Missed. In the confirmation dialog, click OK.

  7. Enter the text Patient's chart has been located and Medical History is available. in the the Reason field. Click Save to unset 3: Form 3 as missed.

  8. Double-click Site 99 - Hospital #99 entry in the record list. This closes all open subject binders for Site 99 - Hospital #99.

4.8. Retrieve and modify existing data using a predefined task and save modifications to the database.

  1. Select Select > By Task to view the list of predefined data entry and data management tasks.

  2. Click Screening Data Review from the list, then Select to load the task and its selection criteria. This task is used to review all screening plate 1s that exist at level 1 or 2 and save them to level 3. Examine the lower left of the dialog to determine the number of records that match the task search criteria.

  3. Click OK to bring forward all records that match the task criteria.

  4. Beginning with the first task record for Subject 99001, press Tab to advance through all fields on the page, comparing their values to those on the CRF image in the image window. When Eligibility Criteria #5 is the current field, select Field > Add Query or click in the Query window.

  5. In the Add Query dialog, set:

    • Category = Other

    • Use = External

    • Status = New query

    • Type = Clarification

    • Detail enter We have not received this patient's informed consent form. Please send it by fax or email without delay.

  6. Click OK to apply the query.

  7. Press Tab to advance through the remaining fields on the page. Once all fields have been traversed, press Tab to make the save buttons active.

  8. Click Incomplete to save the current task record to the database at level 3.

  9. Batch validate the remaining records in the task list to raise their level to level 3. Select Select > Batch Validate. In the dialog, set:

    • Move record level to = 3 - Level 3

    • Choose All currently selected task records

    Click Batch Validate....

  10. Enter Username of valid1 and the corresponding password in the verification dialog. Click OK to batch validate the task records to level 3 and dismiss the dialog.

  11. Review the details in the summary dialog. Click OK to close the summary dialog and complete the batch validation operation.

4.9.  Confirm audit trail information for entered and modified data.

  1. Return to Subject 99001 > 0 : Screening Visits > 1 : Form 1.

  2. Select Plate > List History of All Changes on This Page to display the current record's history.

  3. Click Close to close the Page History dialog.

  4. Select File > Exit menu to close and exit DFexplore.

4.10. End Module 4.

  • Return to the DFATK application. Click End to confirm successful completion of Module 4.

Chapter 5. Module 5: Image Data Entry

5.1. Tests & Requirements

  1. Submit PDF images to DFexplore.

  2. Login to DFexplore and confirm the receipt of new pages in the Status View.

  3. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.

  4. Login to DFexplore and confirm receipt of the routed page in the Status View.

  5. Retrieve new images in DFexplore Image View.

  6. Enter Plate 1 (Form 1) for Subject 99002.

  7. Enter Plate 2 (Form 2) for Subject 99002.

  8. Enter Plate 3 (Form 3) for Subject 99002.

  9. Enter Plate 4 (Form 4) for Subject 99002.

  10. Compare the resolutions between Standard Definition (SD) version of an image and High Definition (HD) version of the same image.

  11. Edit an existing query.

  12. Delete an existing query.

  13. Change data and record a reason for data change.

  14. Batch validate all opened pages for Subject 99002 to level 2.

  15. Confirm the status of entered pages in Status View.

Estimate of Time Required: 15 Minutes

5.2. Begin Module 5

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 5 followed by Begin to begin this module.

5.3. Send PDF images to DFexplore.

  1. Click Send ID 99002 to email a copy of ID99002.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the ID99002.pdf file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

  2. Start DFsend as described in Section 1.8, “How to start DFsend.

  3. Click Add. From the Select PDF Files file selection dialog, locate the previously saved ID99002.pdf file. Select the file, Click Open.

    [Note]Note

    Alternatively documents can also be added by dragging-and-dropping the desired PDF files from a local file folder directly into the list area.

  4. Click Send. In Verify Password dialog, enter valid1 in the Username field and the previously assigned password in the Password field. Click OK.

  5. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  6. Click Show Log to reveiw the DFsend transmission history to DFexplore.

  7. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

5.4. Login to DFexplore and confirm the receipt of new pages in the Status View.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select View > Status. Examine the count displayed for Images awaiting review in Image Queue.

    [Note]Note

    Although 14 records were submitted, only 12 will be awaiting validation. The first page in the document consists of the cover page (having no barcode), and one plate has an unreadable barcode. As the barcode could not be identified for either page, both have been routed to the Image Router instead of to 254 Acceptance Test Study.

  3. Select File > Close Study to return to the login dialog and list of available studies.

5.5. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.

  1. In the DFexplore login dialog, click Image Router to open the Image Router.

  2. Locate the cover page shown below by selecting the page from the list of images in the CRF ID window.

    [Note]Note

    Any pages that have been received and which DFdiscover could not identify as CRFs for any of the studies registered at your site, will be found in the Image Router. If there are more pages than those added by execution of the DFATK, you may need to locate the 254 Acceptance Test Study cover page in the listing of images.

  3. Select Action > Discard to delete the cover page.

  4. Click OK to delete the cover page from the Image Router.

  5. Locate the CRF for Subject Number 99002, Plate 1, Sequence 0 (Form 1), and select the page from the list of images in the CRF ID window.

  6. Select Action > Rotate/Shift/Identify to correctly identify the CRF for Subject 99002, Plate 1, Sequence 0.

  7. Click leftmost end of the horizontal barcode line. Drag the cross-hairs across the solid barcode line then click rightmost end of the line.

  8. Select 254 - Acceptance Test Study from the drop-down list. Enter Plate and Visit numbers, as illustrated. Click Identify to identify the record.

  9. Select File > Close Image Router to exit the Image Router and return to the DFexplore login dialog.

5.6. Login to DFexplore and confirm receipt of the routed page in the Status View.

  1. Select 254 Acceptance Test Study then click Continue to open its database. If the list of studies closes before a selection is made you will need to log back into DFexplore by re-entering the Username and Password for user valid1.

  2. Select View > Status to examine the count displayed for Images awaiting review in the Image Queue. This count has increased by 1 as a result of a misidentified page being routed.

5.7. Retrieve new images in DFexplore Image View.

  1. Select View > Image. In the Automatic Retrieval dialog,

    • Set Save level = 1 - Level 1

    • Check (enable) Enable Edit Checks

    • Select = document

    • By Age = oldest

    • Quantity __ documents = 10

    • Check (enable) Repeat

  2. Click OK in the Automatic Retrieval dialog to bring forward all new images awaiting data entry.

5.8. Enter Plate 1 (Form 1) for Subject 99002.

  1. With the first page of BLOOD PRESSURE SCREENING VISITS for Subject 99002 displayed, make the page active for data entry by clicking anywhere on the page background using the mouse.

    [Note]Note

    In your normal image entry process, you must always pay careful attention to the accuracy of the ICR data. You will need to do the same here. It is possible that the new pages contain ICR errors that you will need to correct during entry. In particular, it is important that you correct any key fields (visit and/or Subject numbers) that may have been mis-read as these are critical to the identification and storage of the data. Note that the ICR data records on your screen may not match exactly those shown in the examples throughout this module.

  2. Correctly enter Patient Number and Patient Initials as per the CRF image. Press Tab to advance to the Age field.

  3. The MissingQC edit check is programmed to pop up a Query note if any of the following fields are left blank: Age, Sex, Screen 1 Date and all Screen 1 blood pressure readings. Test this edit check on the Age field by making this field blank. Press Tab to exit the Age field. When the Add Query window pops up, click Cancel to ignore and return to complete the field as per the CRF image, before proceeding to the next field.

  4. Enter the Sex and Race fields as they appear on the CRF image. Press Tab to advance to the Screen 1 date field and enter its value 05/01/16 followed by all blood pressure readings for Screen 1 date.

  5. The ScreenDates edit check is executed on exit from the Screen 2 Date field. It checks that the Screen 2 Date follows the Screen 1 Date by at least one day. Enter a Screen 2 Date of 04/01/16, which precedes the Screen 1 Date of 05/01/16, then press Tab to exit the field. After verifying the message in the Add Query confirmation dialog, click OK.

  6. Return to the Screen 2 date field and enter the date and all Screen 2 blood pressure values as they appears on the CRF image.

  7. Step 1 to Step 6 test the entry of specific data fields. Any field that has not been correctly entered (by you or the DFdiscover ICR) is now completed by entering the values as they appear on the CRF image. After entering the last data field Eligibility Criteria #6, press Tab to exit the field to make the Save buttons at the bottom of the data entry window active.

  8. As no data problems exist on the entered page, the page can be saved to the database with a status of Final. Do this by clicking Final with the mouse or by pressing the space bar.

5.9. Enter Plate 2 (Form 2) for Subject 99002.

  1. Correctly enter Patient Number per the CRF image. Press Tab to advance to the Patient Initials field. The SetInit edit check automatically completes the Patient Initials field if the initials are available on the Screening Form (Plate 1).

    [Note]Note

    The Patient Number must be entered correctly on the data record for the SetInit edit check to execute. When an edit check changes a field's value, the changed field will automatically be assigned a default reason and the field's color will change to green to show that an approved reason exists.

  2. Correctly enter the Entry Date, Medication Code # and Date of Birth values per the CRF image. The CheckAge edit check calculates the Subject's age from the Entry Date and Date of Birth fields, and compares this value with the value entered for Age on Plate 1. If these values disagree, an error message is displayed. Press Tab to exit Date of Birth field to execute the CheckAge edit check.

  3. Click OK in the error message window to bring forward the query dialog. Click OK in the query dialog to attach a query to the Date of Birth field.

  4. Press Tab to advance to the Weight (kg) field. Do not enter a value as the corresponding field on the CRF image is blank. Continue on to the Weight (lbs) field and enter the value that appears on the CRF image. If only one of the 2 weight fields are completed, the WeightEquiv edit check calculates and enters the equivalent value for the blank Weight field. Press Tab to exit the Weight (lbs) field executing the WeightEquiv edit check.

  5. Press Tab to advance to the Height (cm) field. Do not enter a value as the corresponding field on the CRF image is blank. Continue on to the Height (in) field and enter the value that appears on the CRF image. If only one of the 2 height fields is completed, the HeightEquiv edit check calculates and enters the equivalent value for the blank Height field. Press Tab to exit the Height (in) field executing the HeightEquiv edit check.

  6. Step 1 to Step 5 test specific data fields. Any field that has not been entered (by you or the DFdiscover ICR) is now completed by entering the values as they appear on the CRF image. After entering the last data field (Date of First Study Follow-up Visit), Press Tab to exit the field to make the save buttons active.

  7. As an outstanding query exists on the Date of Birth field, the page must be saved to the database with a status of Incomplete. Click Incomplete with the mouse or by pressing the space bar.

    [Note]Note

    If outstanding queries and/or illegal values exist on a data record, DFdiscover will never allow the record to be assigned the status Final.

5.10. Enter Plate 3 (Form 3) for Subject 99002.

  1. Plate 3 has been incorrectly identified by DFdiscover as Plate 7 (the data record and CRF image do not match). Before data entry can begin, the record must first be correctly identified by correcting the barcode. To do this, select Plate > Change Barcode.

  2. In the Change Barcode dialog, set the Page to 003. Do this by clicking ... to display a listing of all defined study plates, then select the entry 003 - Medical History from the list. Click OK to close the dialog.

  3. Set the Visit by clicking ... to display a listing of all defined study visits, select 1 - Baseline from the list. Click OK to close the visit listing dialog. Click OK.

  4. Confirm the change to the barcode by clicking OK in the warning dialog.

    [Note]Note

    When a barcode is changed, all data fields on the data record (top half of the screen), will be blanked of their previous ICR values as these are no longer correct. The correct values must be entered manually.

  5. Correctly enter Patient Number as per the CRF image. Press Tab to advance to the Patient Initials executing the SetInit edit check as in Section 5.9, “Enter Plate 2 (Form 2) for Subject 99002.”.

  6. Press Tab to advance to the 1. Hypertension No/Yes field and check the response indicated on the CRF image. Press Tab to advance to the Duration, Years field and leave it blank as per the CRF image. Press Tab to advance to the Duration, Months field and enter the number of months 06 as they appear on the CRF image. The MedHxDur edit check completes the Duration fields by entering zeros into the Years field if only Months are given, and zeros into the Months field if only Years are given. Press Tab to exit the Duration, Months field to execute the MedHxDur edit check.

  7. Enter the remaining values for 1. Hypertension and enter all fields for 2. Atrial Fibrillation. Press Tab to advance to the first No/Yes field for 3. Other Cardiac EG Arrhythmia.

  8. A skip has been set on the No/Yes fields for each medical history item such that if "No" is selected, the remaining fields for that medical history item are skipped and the user is taken to the next item. Enter the correct values for medical history items 3. to 6. to execute the skip.

  9. Enter all values for 7. Diabetes up to and including the Currently on Treatment field. Press Tab to advance to the Resolved and/or Controlled field which has been left blank on the CRF image. Select Field > Add Query or click . In the Add Query dialog, set:

    • Category = Missing

    • Status = New query

    • Use = External

    • Type = Correction

    Click OK.

    [Note]Note

    DFexplore attempts to complete the Problem, Status, Use and Type information when a query is being added. It is important to verify the query settings and correct them if necessary, before applying the query to the data field.

  10. For medical history items 8. to 11., enter the appropriate values per the CRF image. Press Tab to advance to the text field for the first 12. Major surgery (specify) to make it the current field.

  11. Enter the correct values in all fields for the first Major surgery input hip replacement up to and including the How long ago response. An edit check, CalcDays, attempts to read the How long ago text field to calculate the number of days prior to study entry that surgery occurred. The calculated value automatically populates the hidden field to the right of these text fields. Pressing Tab off the How long ago field executes CalcDays edit check.

  12. Press Tab to advance to the 2nd Major surgery item input endarterectomy and perform the same steps as in Step 11. Enter the date 06/07/95 for July 6/95 in the How long ago field.

  13. Step 5 to Step 12 test specific data fields. Any field that has not been entered (by you or the DFdiscover ICR) is now completed by entering the values as they appear on the CRF image. After entering the last data field, press Tab off the field to make the save buttons at the bottom of the data entry window active.

  14. Click Incomplete with the mouse or by pressing the space bar. As an outstanding query exists on the 7. Diabetes, Resolved and/or Controlled field, the page must be saved to the database with a status of Incomplete.

5.11. Enter Plate 4 (Form 4) for Subject 99002.

  1. Correctly enter Patient Number, Patient Initials and both Medications Page Number fields per the CRF image. As for the previous pages, the SetInit edit check automatically completes the Patient Initials field. Press Tab to advance to the 1. Drug Name field.

  2. In 1. Drug Name type the text Inderal as it appears on the CRF image . The Drug Name fields have been mapped to lower case in their setup definitions. Therefore, all entered text will appear as lower case regardless of the case typed.

  3. Enter all data for the first 2 drugs (Inderal and ASA) as it appears on the CRF image. The CalcDays edit check that is present on Plate 3 (Medical History) is also present on the Start Date or Duration of Use fields. During data entry, confirm that the hidden fields contain the calculated values as shown below.

  4. Press Tab to advance to the 3. Drug Name field. An edit check, DrugLookup, has been programmed to match the entered drug text with an entry in a drug in the lookup table. Enter the 3rd drug name 222s and press Tab to exit the field executing DrugLookup edit check. (If an entry can not be found in the lookup table, a search dialog is displayed.)

  5. In the search dialog,

    • Check (enable) Acronym

    • Uncheck (disable) Result

    • Input (enter) 222 in the Search terms

    Click Find. Once the match asa with codeine (222) is found, click OK.

  6. Enter the remaining values for the 3rd drug field and press Tab to advance to 4. Drug Name field. A skip has been set on each of the Drug Name fields such that if the field is blank, the remaining fields for that drug are skipped. Press Tab to advance through the remaining Drug name fields, and leave them blank as per the CRF image, to execute the skip.

  7. Step 1 to Step 5 test specific data fields. Any field that has not been entered (by you or the DFdiscover ICR) is now completed by entering the values as they appear on the CRF image. After entering the last data field, press Tab to exit the field and make the save buttons at the bottom of the data entry window active.

  8. As no data problems exist on the entered page, the page can be saved to the database with a status of Final. Do this by clicking Final with the mouse or by pressing the space bar.

5.12. Compare the resolutions between Standard Definition (SD) version of an image and High Definition (HD) version of the same image.

  1. With Monthly Follow-up Form for Subject 99002 as the active page, verify that the button is shown at the bottom-right corner of the main data entry screen. Examine the quality of the SD image.

    [Note]Note

    DFexplore remembers this setting from the last use. If module 5 was previously executed, the button will already show . In this case, continue with Section 5.13, “Edit an existing query.”.

  2. Five hidden buttons , , , and can be displayed and identified at the bottom-left corner of the main data entry screen. To show these buttons, place the mouse anywhere on the image. To identify each button, hover the mouse over top of it.

  3. Click until the image reaches its maximum size. Examine the enlarged SD image.

  4. Click at the bottom-right corner of the data entry screen, switching the label to . Confirm that the background color of is green as shown.

  5. Examine the HD image. Verify that the HD image is clearly visible and there is a noticeable difference between the HD image and the previous SD image.

5.13. Edit an existing query.

  1. Select View > Queries to change from Image View to Queries View.

  2. Click OK in the confirmation dialog to release the Image View records and open Queries View.

  3. In the Queries View site list, double-click icon Site 99 - Hospital #99 to list the queries for that site. Select Show > Outstanding Queries to display all outstanding/unresolved queries for Site 99 - Hospital #99.

  4. Locate the query for Subject 99002, Baseline : Form 3. This is the query that was added to the field 7. Diabetes, Resolved and/or Controlled in Section 5.10, “Enter Plate 3 (Form 3) for Subject 99002.”. Double-click the query entry to be taken directly to the page and queried field.

  5. Select Select > Change Mode & Level. In the dialog, set:

    • Mode = Validate

    • Save level = 2 - Level 2

    • Check (enable) Enable edit checks

    Click OK to apply the changes.

  6. Select Field > Edit Query or click . In the dialog. Set:

    • Status = Resolved NA from the pull-down list.

    • Enter The Subject is currently on treatment. in the Detail field

    Click OK to apply the edits.

5.14. Delete an existing query.

  1. The queried field 7. Diabetes, Resolved and/or Controlled maintains the focus from Section 5.13, “Edit an existing query.”. If not, make it the current field. Select Field > Delete Query or click .

  2. Click OK to perform the query deletion.

  3. Click Delete in the Delete Query confirmation dialog.

5.15. Change data and record a reason for data change.

  1. With Form 3, Medical History as the current page, press Tab to advance to 11. Other (specify). Change the existing data value of arthritis to arthritis (knees) and select Field > Add Reason for Data Value or click .

  2. In the Reason for Data Value dialog, confirm that the Old Value and New Value fields display the data values shown. Choose Pending from the status list to change the reason's Status to Pending. Enter the text Location of arthritis (knees) was provided verbally by the site. in the Reason field. Click OK to close the dialog and save the reason for data change to the database. Press Tab to advance to the next field.

  3. Press Tab to advance through the remaining fields on the Medical History page until the save buttons at the bottom of the screen become active. Click Final to save the modified page to the database at level 2.

5.16. Batch validate all opened pages for Subject 99002 to level 2.

  1. Still working at Save Level 2 with the pages previously opened for Subject 99002, select Select > Batch Validate.

  2. Choose 2-Level 2 from the Move record level to pull-down list. Choose All open pages for current subject. Click Batch Validate....

  3. Enter valid1 as the Username and the previously assigned password. Click OK to batch validate the selected records.

  4. Click OK to close the summary dialog and complete the batch validation operation.

5.17. Confirm the status of entered pages in Status View.

  1. Select View > Status to close Image view and release all pages in the record list and open Status view.

  2. Confirm that the number of images awaiting review is now 9.

  3. Select File > Exit to close and exit DFexplore.

5.18. End Module 5.

  • Return to the DFATK application. Click End to confirm successful completion of Module 5.

Chapter 6. Module 6: User-Defined Query Category Types

6.1. Tests & Requirements

  1. Retrieve an existing data record in DFexplore.

  2. Apply a user-defined Query Category query.

  3. Add a reason for Data Value to explain entered data.

  4. Edit an existing query.

  5. Remove a user-defined Query Category that is used by an existing query.

  6. Delete a user-defined Query Category query.

Estimate of Time Required: 30 Minutes

6.2. Begin Module 6.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 6 followed by Begin to begin this module.

6.3. Retrieve an existing data record in DFexplore.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select Select > Change Mode & Level. Within the dialog, set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check (enable) Enable edit checks

    Click OK to apply these settings.

  3. Double-click the folder for Site 99 and then double-click subject 99007 in the record list to open the subject binder. Locate the 0: Screening Visits in the list of assessments for subject 99007, and double-click this entry to open task records for this subject. Press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field.

6.4. Apply a user-defined Query Category query.

  1. With Screen 2, Reading 1 systolic blood pressure as the current field, select Field > Add Query or click to open the Add Query dialog. In dialog, confirm that Test, Monitor and Clinical QC are present in the Category pull-down list. Set:

    • Category = Test

    • Use = External

    • Type = Clarification

    • Status = New query

    • Detail = This value is out of our reference range. Please review.

  2. Click OK to apply the query to the Screen 2, Reading 1 systolic blood pressure field. Note that the field becomes blue. Examine the details in the Query window that appears near the bottom left of the screen.

  3. Press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Incomplete to save the page.

6.5. Add a reason for Data Value to explain entered data.

  1. With Blood Pressure Screening Visits as the active page, press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field. Select Field > Add Reason For Data Value or click to open Reason for Data Value dialog.

  2. Enter The value 180 mmHg for systolic blood pressure has been confirmed. Clinical significance is being evaluated. in the Reason field.

  3. Click OK to apply the reason to the Screen 2, Reading 1 systolic blood pressure field. Note that this field is the current field and the field becomes orange. Examine the details in the Reason window that appears near the bottom left of the screen.

    [Note]Note

    If a user-defined Query Category Code is specified as auto-resolution in DFsetup, adding a reason to a field that has a query with such a problem type will change the query status from outstanding to pending.

  4. From the Screen 2, Reading 1 systolic blood pressure field, press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the Save buttons at the bottom of the data screen to make them active. Click Final to save the page to the database.

6.6. Edit an existing query.

  1. Select View > Queries. Select Show > Pending Queries to display all pending queries for Site 99 - Hospital #99.

  2. Double-click entry for subject 99007, Screening Visits: Form 1 to be taken directly to the page and the pending field.

  3. In Data View, select Select > Change Mode & Level. In the dialog, set:

    • Mode = Validate

    • Save level = 2 - Level 2

    • Check Enable edit checks

  4. Click OK to apply and close the Change Mode & Level dialog. The current field is Screen 2, Reading 1 systolic blood pressure.

  5. Select Field > Edit Query or click . In the dialog,

    • Set Use as Internal

    • Delete the existing text in the Detail field

    • Enter See Reason for Data Value. in the Note field

    Click OK to apply the edits.

  6. From the Screen 2, Reading 1 systolic blood pressure field, press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Final.

  7. Select File > Exit to close and exit DFexplore.

6.7. Remove a user-defined Query Category that is used by an existing query.

  1. Start DFsetup and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  2. Choose Normal Access and click OK.

  3. Select View > Query Category Map.

  4. In the Query Category Map dialog, locate the entry that has Query Category Code 30 and Label Test. Click entry to highlight it, then click Delete. Click Save and Done.

  5. Select File > Exit to close DFsetup.

6.8. Delete a user-defined Query Category query.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Double-click the folder for Site 99 - Hospital #99 to display a list of available subjects. Double-click subject entry 99007 in the subject list to open the subject binder. Locate the 0: Screening Visits assessment for subject 99007 and double-click this entry. Press Tab to advance through the fields until Screen 2, Reading 1 systolic blood pressure becomes the current field. Examine the details in the Query window. If an existing query contains a user-defined problem type, and that problem type definition has been removed from DFsetup, the query in DFexplore displays Query Category Code 30 as category.

  3. Select Field > Delete Query or click .

  4. Click OK to perform the query deletion.

  5. Click Delete in the confirmation dialog.

  6. Press Tab to advance through the remaining fields on the Blood Pressure Screening Visits page until the save buttons at the bottom of the screen become active. Click Final.

  7. Click File > Exit to exit DFexplore.

6.9. End Module 6.

  • Return to the DFATK application. Click End to confirm successful completion of Module 6.

Chapter 7. Module 7: Multiple Queries Per Field

7.1. Tests & Requirements

  1. Submit PDF images to DFexplore.

  2. Enable multiple queries per field in DFsetup.

  3. Retrieve submitted CRF in DFexplore Image View.

  4. Enter Plate 9 for Subject 99002.

  5. Apply multiple queries to a field.

  6. Select and edit an existing query in a field that has multiple queries.

  7. Select and reply to an existing query in a field that has multiple queries.

  8. Select and delete an existing query in a field that has multiple queries.

Estimate of Time Required: 30 Minutes

7.2. Begin Module 7.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 7 followed by Begin to begin this module.

  3. The following steps require exclusive access to the 254 Acceptance Test Study database. To facilitate exclusive access, close DFATK by clicking Exit.

7.3. Submit PDF images to DFexplore.

  1. Click Send ID 99002 to email a copy of ID99002-module7.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the ID99002-module7.pdf file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

  2. Start DFsend as described in Section 1.8, “How to start DFsend.

  3. Click Add. From the Select PDF Files file selection dialog, locate the previously saved ID99002-module7.pdf file. Select the file, Click Open.

    [Note]Note

    Alternatively documents can also be added by dragging-and-dropping the desired PDF files from a local file folder directly into the list area.

  4. Click Send, enter valid1 in the Username field and the previously assigned password in the Password field. Click OK.

  5. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  6. Click Show Log to confirm successfull transmission of the ID99002-module7.pdf file to DFexplore.

  7. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

7.4. Enable multiple queries per field in DFsetup.

  1. Start DFsetup as datafax and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  2. Choose Developer Access in the Access mode dialog, click OK.

  3. The main window for DFsetup is displayed. Select Study > Global Settings.

  4. Click Global tab in the Global Settings dialog.

    Check (enable) if not already checked Allow multiple queries per field.

    The warning message: This CANNOT be undone once the Study Setup is saved is displayed.

  5. Click OK to close the Global Settings dialog.

  6. Select File > Save [Required], followed by File > Exit.

7.5. Retrieve submitted CRF in DFexplore Image View.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. The main window for DFexplore is displayed. Select View > Image.

  3. In the Automatic Retrieval dialog, set:

    • Save level = 1 - Level 1

    • Check (enable) Enable Edit Checks

    • Select = document

    • By Age = Oldest

    • Quantity __ documents = 25

    • Check (enable) Repeat

    Confirm the settings.

    Click OK.

  4. The first image retrieved is the Adverse Event Report CRF.

7.6. Enter Plate 9 for Subject 99002.

  1. The Adverse Event Report No. field is highlighted as the current field. Enter the value from the CRF image if it is not already correctly auto-filled. Press Tab to advance to the AE Identifier field. The AESEQNUM2 edit check executes upon entry to the AE Identifier field. The data value in the field is updated.

  2. Press Tab to advance to the Patient Number field.

  3. Beginning at the Patient Number field, correctly enter the data per the CRF image, up to and including the Intensity field. Tabbing from the Intensity field, a user-defined edit check executes and the dfaddqc: Severity dialog is displayed.

  4. Click OK to apply the edit check. The field becomes blue, and the next field Relationship to Study Drug becomes the current field.

  5. Correctly enter each data field on the page per the CRF image, up to and including the Description field.

    Do not enter any text in the Description field as the corresponding field on the CRF image is blank. Upon tabbing off this field, the dfaddqc: MissingQC dialog appears.

    Confirm that Missing is displayed in the Query category field.

  6. Click OK. This applies the edit check to the Description field. The field becomes blue, and the AECOTERM becomes the current field.

  7. From the AECOTERM field, press Tab through all remaining fields until the Investigator's Signature field becomes the current field.

    Tabbing from the Investigator's Signature field, the DFlookup: investigators dialog appears. Highlight Dr. John Snow and click OK.

  8. Enter the Date field value. Press Tab to advance to the save status bar to make it active. Click Incomplete.

7.7. Apply multiple queries to a field.

  1. With the Adverse Event Report displayed as the current page, make the page active by clicking anywhere on the page background using the mouse. Press Tab to advance through the fields until Description becomes the current field. Note that the Description field is blank and has an unresolved query with the category Missing (external, correction). Enter the text Nausea, ??? and fever.

  2. Select Field > Add Query or click . In the dialog, confirm Category type Missing is disabled. Set:

    • Category = Other

    • Use = External

    • Type = Correction

    • Status = New query

    • Detail = Please clarify the word after nausea. The description provided through email is 'Nausea, vamit and fever'. Do you mean Vomit instead?

    [Note]Note

    Multiple queries can be added to a single field, but each query must have a unique Query Category type. Therefore, a Query category will be disabled if it has been previously used on the same field where a new query is to be added.

  3. Click OK to apply the query. Confirm that the Description field is the current field with the query count '2' displaying on the top left corner of the field widget, and the field becomes blue.

  4. With the focus still on the Description field, examine the details in the Query window that appears at the bottom left corner of the main data entry screen.

  5. Select Field > Add Query or click to add the third query to the Description field. In the dialog, set:

    • Category = Monitor

    • Use = External

    • Type = Correction

    • Status = New query

    • Detail = Nausea and fever are two separate adverse events and should be reported in different CRFs. Please review.

  6. Click OK to apply the query. Confirm that the Description field is the current field with the query count 3 displaying on the top left corner of the field widget, and the field becomes blue.

  7. With the focus still on the Description field, examine the details in the Query window that appears at the bottom left corner of the main data entry screen.

    [Note]Note

    The query list is presented in accordance with the query sort order that has been defined by the user in DFsetup Query Category Map.

  8. Press Tab to exit the Description field, and a DFlookup: aecodes window appears. Click Cancel in the window to close the dialog. The next field AECOTERM becomes the current field.

  9. Press Tab to advance through the remaining fields on the page without making any changes. Press Tab to advance to the save buttons at the bottom of the data screen to make them active. Click Incomplete.

7.8. Select and edit an existing query in a field that has multiple queries.

  1. With the Adverse Event Report page still being the active page, select View > Queries to open the Queries View window. In the resulting confirmation dialog, click OK to release all Image records. Select Show > All Queries. Double-click Site 99 - Hospital #99. Locate and confirm that the Queries window displays the three queries that have been applied to the AE Description field for Subject 99002.

  2. Select Show > Outstanding Queries. Locate and confirm that two unresolved queries with categories Other and Monitor on the AE Description field of Subject 99002 are displayed.

  3. Double-click entry containing the query category Other in the Description field of Subject 99002, Adverse Event 1 Page 1: Form 9, AE Report 011.

  4. Select Select > Change Mode & Level. In the dialog, set:

    • Mode = Validate

    • Save level = 2 - Level 2

    • Check (enable) Enable edit checks

    Click OK to apply the changes.

  5. Delete the text ??? in the description field and enter vomiting instead. Examine the query window. From the Query drop-down choose Other (external, correction) query in the query list.

  6. With the focus on the Other (external, correction) query Description field, select Field > Edit Query, or click the to open the dialog. set:

    • Select Pending from the Status pull-down.

    • Enter The correction was provided via email. in the Note field.

    Click OK to apply the edits.

7.9. Select and reply to an existing query in a field that has multiple queries.

  1. Select Monitor (external correction) from the Query pull-down to make the query active.

  2. Select Field > Reply to Query or click to open the dialog. Enter Fever will be removed to a different Adverse Event Report form. in the New Reply field.

  3. Click OK to close the dialog. Examine the information present in the Query window.

7.10. Select and delete an existing query in a field that has multiple queries.

  1. Choose Missing (external, correction) from the Query pull-down list. The query list in the query window displays the Missing (external, correction) query. Confirm that the first query is defined with Category: Missing (external, correction) and a Status: Resolved corrected.

  2. Select Field > Delete Query or click to open the Delete Query window.

  3. Click OK to perform the query deletion.

  4. Click Delete in the Delete Query confirmation dialog. Confirm that the Description field remains as the active field and has the query count 2 displaying on the top left corner of the field widget.

  5. Press Tab to exit the Description field, and a DFlookup: aecodes window appears. Click Cancel in the window to close the dialog. The next field AECOTERM becomes the current field.

  6. Press Tab to advance through the remaining fields on the Adverse Event Report page until the Incomplete at the bottom of the screen becomes active. Click Incomplete to save the modified page to the database.

  7. Select File > Exit to close and exit DFexplore.

7.11. End Module 7

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click End to confirm successful completion of Module 7.

Chapter 8. Module 8: Double Data Entry (DDE)

8.1. Tests & Requirements

  1. Retrieve a set of records for entry by Double (2nd pass) Data Entry (DDE).

  2. Perform DDE such that discrepancies exist between the new DDE values and the original data values.

  3. Programmed edit checks execute as expected during DDE.

  4. Verify the audit trail of DDE data.

Estimate of Time Required: 20 Minutes

8.2. Begin Module 8.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 8 followed by Begin to begin this module.

8.3. Retrieve a set of records for entry by Double (2nd pass) Data Entry (DDE).

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select Select > By Data Fields to open the Select by Data Fields dialog, set:

    • Mode = DDE

    • Save level = 3 - Level 3

    • Check (enable) Enable edit checks

    • Search = By program

  3. Enter DFmkdrf.jnl -t 150101-today -u valid1 -image yes in the Program field. Click Done to apply the retrieval criteria.

    [Note]Note

    The above program command will retrieve all data records entered from 2015/01/01 to the current date by user valid1 and include the CRF images if they exist.

  4. Click OK to retrieve all records that match the specified criteria.

  5. Double-click Subject 99002 to open the subject for double data entry.

    [Note]Note

    DDE mode presents the user with records in which all data fields, except the Patient Number, are blanked.

8.4. Perform DDE such that discrepancies exist between the new DDE values and the original data values.

  1. On the Blood Pressure Screening Visits form for Subject 99002, press Tab to advance through the fields, entering the data values as they appear on the corresponding CRF image. When Sex becomes the current field, check the Female response instead of the Male response. Press Tab to exit the field.

  2. In the DDE Discrepancy dialog, click New Value to apply the newly entered value of female. Confirm that the Old Value is male and the New Value is female.

  3. Select Pending from the Status pull-down list. Enter Value changed to Female during double data entry. in the Reason field. Click OK to save the new value and reason for data change.

    [Note]Note

    An orange field indicates that there is a reason or query that is pending approval by the study's central data management site.

  4. Press Tab to advance through the remainder of the fields on the Blood Pressure Screening page, correctly entering the data values as they appear on the corresponding CRF image. Verify that the Save information bar at the bottom of the screen indicates that the saved page will be assigned a record level of 3.

  5. Press Tab to exit the last data field so that the save buttons get the focus. Click Final to save the page to the database.

  6. Click entry for 9: Form 9, AE Report 011 in the record list to open the Adverse Event Report.

  7. Click anywhere on the page background to make the page active. Press Tab to exit the auto-filled Adverse Event Identifier field and the Patient Number field to advance to the Patient Initials field. Upon entry the Patient Initials field, the correct initials JAM automatically occupy this field as a result of the edit check SetInit described in Module 5: Image Data Entry.

    [Note]Note

    If there are no discrepancies during DDE, queries and reasons (if available) added to the field during original data entry, are brought forward. When meta data is brought forward, the field changes to the color associated with the type of meta data.

  8. Press Tab to advance through the fields, entering the data values as they appear on the corresponding CRF image. When Description becomes the current field, enter Nausea and vomiting. Press Tab to exit the field.

  9. In the DDE Discrepancy dialog, click New Value to apply the newly entered text Nausea and vomiting. Upon leaving the Description field, the DrugLookup edit check is executed and DFlookup:aecodes dialog appears. Click Cancel to close the DFlookup:aecodes dialog.

  10. Continue tabbing through the remainder of the fields on this page, up to and including the Investigator's Signature field. Without entering any values, Press Tab to exit this field and the DDE Discrepancy dialog appears. In the dialog, confirm the Old Value is Dr. John Snow and the New Value is (none). Click Old Value.

  11. Enter the date as it appears on the CRF image. Press Tab to exit the last data field so that the save buttons at the bottom of the screen become active. Click Incomplete to save the page to the database and assign a record level of 3.

8.5. Programmed edit checks execute as expected during DDE.

  1. Double-click Subject 99002 in the record list, click 2: Form 2 to make the Patient Entry Form the current page. Click anywhere on the page background to make the page active. Confirm that the Patient Number is correct then press Tab to advance to the Patient Initials field. Confirm the initials JAM.

  2. Press Tab to advance through and enter the fields as they appear on the CRF image up to and including the Date of Birth field. Press Tab to exit the Date of Birth field and examine the field color.

  3. Leave the Weight (kg) field blank per the CRF and press Tab to advance to the Weight (lbs) field.

  4. The discrepancy is detected because the edit check WeightEquiv that calculates the weight in kg, executes on exit of the Weight (lbs) field and therefore has not yet been triggered. In the DDE Discrepancy dialog, click Old Value.

  5. Enter the correct data value in the Weight (lbs) field, press Tab to exit the field.

  6. Leave the Height (cm) field blank per the CRF and press Tab to advance to the Height (in) field.

  7. The discrepancy is detected because the edit check HeightEquiv that calculates the height in cm, executes on exit of the Height (in) field and therefore has not yet been triggered. In the DDE Discrepancy dialog, click Old Value.

  8. Enter the correct data value in the Height (in) field, press Tab to exit the field.

  9. Beginning with the Pulse field, enter the data values as they appear on the CRF image. When the save buttons become active, click Incomplete. The record must be signed-off as “Incomplete” as a result of the query present on the Date of Birth field.

8.6. Verify the audit trail of DDE data.

  1. Double-click Subject 99002 > 0 : Screening Visits > 1 : Form 1 (Blood Pressure Screening Visits).

  2. Select Plate > List History of All Changes on This Page to display the current record's history from the system journal files. Locate those entries that contain the date on which DDE was performed in this module.

  3. Click Save As Excel in the resulting dialog enter 99002-history.xlsx as the Output File . Check Open output file after export, click Save. Click Close to close the dialog.

  4. Double-click Form 2 for Subject 99002 to make it the active page. Select Plate > List History of All Changes on This Page to display the current record's history from the system journal files. Locate those entries that contain the date on which DDE was performed for this module.

  5. Click Close.

  6. In the record list window, select Form 9 for Subject 99002 to make it the active page. Select Plate > List History of All Changes on This Page to display the current record's history from the system journal files. Locate the entry for the Description field and confirm that existing multiple queries in this field are listed.

  7. Select File > Exit to release the DDE task record set and exit DFexplore.

8.7. End Module 8

  • Return to the DFATK application. Click End to confirm successful completion of Module 8.

Chapter 9. Module 9: Data Review

9.1. Tests & Requirements

  1. Retrieve all data for Site 99 that exists at level 3.

  2. Review and approve a pending reason for data value, and approve a selected query in a field that has multiple queries.

  3. Review and move approved reasons for data values to a higher workflow level, and review queries in a field that has multiple queries.

  4. Data review and add a query to inconsistent data.

  5. Review and complete pending data for Subject 99007.

  6. Confirm audit trail information for reviewed and modified data.

  7. Run batch edit checks to verify data integrity.

  8. Use a data expression to retrieve specific subject information.

  9. Use cross-plate data criteria to retrieve specific subject information.

Estimate of Time Required: 20 Minutes

9.2. Begin Module 9.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 9 followed by Begin to begin this module.

  3. Click Send ID 99007 to email a copy of ID99007_module9.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

9.3. Retrieve all data for Site 99 that exists at level 3.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select Select > By Data Fields from the menubar to open the Select By Data Fields retrieval dialog. In the dialog, set:

    • Mode = Validate

    • Save level = 4 - Level 4

    • Search = Data

    • Level = 3

    • Check (enable) Enable edit checks

  3. Click Done. In the confirmation dialog, click OK to retrieve data records that match the criteria.

  4. Double-click entry for Subject 99002 to open the subject binder.

9.4. Review and approve a pending reason for data value, and approve a selected query in a field that has multiple queries.

  1. 1: Form 1, Blood Pressure Screening Visits for Subject 99002 is the active page. Press Tab to advance to the Sex field. Examine the information in the Reason for Data Value window.

  2. Select Field > Approve Queries and Reasons. Examine the information in the dialog.

  3. Select Approved from the Status pull-down. Confirm that the approved reason will be moved from level in the database.

  4. Click Save and Done to close the dialog.

  5. Do not make any other changes to the data on the current page and press Tab to advance to the save buttons. Click Final to save the page and its reason at level 4.

  6. Click 9: Form 9, AE Report 011..

  7. Click anywhere on the page background to make the fields active. Press Tab to advance to the Description field. Examine the information displayed in this field and the information in the corresponding Query window.

  8. Select Field > Approve Queries and Reasons. Select the Monitor query. Examine the information in the dialog.

  9. Select Resolved corrected from the Status in the Query section. Confirm that the CRF will be moved from level in the database, and Status from Pending to Resolved corrected.

  10. Click Save. Upon clicking Save, the Approve Queries and Reasons dialog changes from displaying the query with problem type Monitor to displaying the query with problem type Other as shown below. Click Done.

  11. Press Tab to exit the Description field. Upon leaving the field, the DrugLookup edit check is executed and DFlookup:aecodes dialog appears. Click Cancel.

  12. Do not make any other changes to the data and press Tab to advance to the save buttons. Click Incomplete to save the page to the database at level 4.

9.5. Review and move approved reasons for data values to a higher workflow level, and review queries in a field that has multiple queries.

  1. Double-click Subject 99002. Select entry for 2 : Form 2. Select Field > Review Queries and Reasons to review all queries and reasons that are present on the page.

  2. Working with the highlighted entry for Patient Initials, confirm that the Status is set to Approved and the level button displays . Click to move the approved reason from level 3 to level 4 without making any other modifications.

  3. Select 3rd Reason entry Weight (kg). Confirm that the Status is set to Approved and is displayed. Click to move the approved reason from level 3 to level 4 without making any other modifications.

  4. Select 4th Reason entry Height (cm). Confirm that the Status is set to Approved and is displayed. Click to move the approved reason from level 3 to level 4 without making any other modifications.

  5. Once each of the 3 approved reasons have been moved to a higher workflow level of 4, click Done.

  6. As an outstanding query remains on the Date of Birth field, click Incomplete to save.

  7. With the Adverse Event Report as the current page, click anywhere in the data entry screen background to make the page active. Press Tab to advance though the fields until the Description field becomes the current field. Select Field > Review Queries and Reasons. Examine the information in the dialog.

  8. Click the second query with the Category type Monitor and a status of 4: External - Resolved corrected. Click Done to close the dialog.

  9. Press Tab to exit the Description field. Upon leaving the Description field, the DrugLookup edit check is executed and DFlookup:aecodes dialog appears. Click Cancel.

  10. Do not make any other changes to the data on the current page and press Tab to advance to the save buttons. Click Incomplete.

9.6. Data review and add a query to inconsistent data.

  1. Double-click Subject 99007 entry in the record list to open task records for this subject. Press Tab to advance through the fields until Screen 1, Reading 1 systolic blood pressure becomes the current field.

  2. Select Field > Add Query or click to open the Add Query dialog. In the dialog, set:

    • Category = Inconsistent

    • Use = External

    • Type = Clarification

    • Status = New query

    • Enter This value is inconsistent with all other BP readings. Please explain. in the Detail field.

  3. Click OK to apply the query.

  4. Press Tab to advance through the remaining fields on the page until the save buttons become active. Click Incomplete to save the page to the database.

9.7. Review and complete pending data for Subject 99007.

  1. Release the current task set and retrieve all pages in the database that have been saved with status Pending. Do this by selecting Select > By Data Fields. In the dialog set:

    • Mode = Validate

    • Save level = 4 - Level 4

    • Search = Data

    • Status = Pending

    Leave the retrieval Level field blank.

  2. Click Done. In the confirmation dialog, click OK to retrieve data records that match the search criteria.

  3. Select Subject 99007 > 1 : Baseline > 3: Form 3 from the record list and click anywhere on the page background to make it the active page. Beginning with the Patient Number field, Press Tab to advance through the fields until the first Major Surgery text field is the current field. Enter all Major Surgery information as it appears on the printed Medical History CRF page for Subject 99007. Press Tab to exit the last data field to make the save buttons active at the bottom of the screen.

  4. As there are no outstanding problems on the page and the data is now complete, click Final to change the page status from Pending to Final at level 4.

  5. Select Select > All Records to release all task records from the current set. Click OK in the dialog to clear the main Data View window.

9.8. Confirm audit trail information for reviewed and modified data.

  1. Select View > Reports, Reports View becomes the current view.

  2. Double-click the Legacy Reports section and choose report DF_ATmods from the list of reports. To review all data modifications made to Subject 99002 and 99007. Enter -t today -I 99002 99007 in the Specify field.

  3. Click Run to execute the DF_ATmods report. Examine the output.

9.9. Run batch edit checks to verify data integrity.

  1. Select View > Batch Edits Batch Edits becomes the current view.

  2. With the Controls tab as the current view. Click File > Open Control File... from the drop-down list.

  3. In the Open Batch Control File dialog, select (enable) the On study server option to display a list of available control files that are located on the study server for the 254 Acceptance Test Study. Choose ScreenDateCheck.xml from the list and click OK to load the control file.

  4. Click Show Batch to ensure the settings are as shown below. Click Hide Batch to hide the settings.

    [Note]Note

    The ScreenDateCheck.xml control file executes the edit check ScreenDates which verifies that the Screen 1 and Screen 2 dates on all plate 1s (Blood Pressure Screening Form) are in sequential order with the Screen 1 date coming before the Screen 2 date.

  5. Click Run Batchlist to run the current batch program.

  6. From the Summary drop-down list, select the output that produces the date and time the report was executed.

  7. The edit check ScreenDates checks the Screen 1 and Screen 2 dates on Form 1 (plate 1) and determines if they are out of sequence. Examine the log entry message.

  8. Double click the entry to be taken to Data View. Examine the values in the Screen 1 and Screen 2 date fields.

  9. Select View > Batch Edits With the Controls tab as the current view, click File > Open Control File... from the drop-down list.

  10. In the Open Batch Control File dialog, select (enable) the On study server option to display a list of available control files that are located on the study server for the 254 Acceptance Test Study. Choose batchSAEcheck from the list and click OK to load the control file.

  11. Click Show Batch to ensure the settings are as shown below. Click Hide Batch to hide the settings.

    [Note]Note

    The batchSAEcheck.xml control file applies a query to Is This A Serious Event field on plate 009 when the response to this field is inconsistent with the value in the Intensity field of the same plate.

  12. Click Run Batchlist to run the current batch program. Enter the Username and Password of the current user, click OK.

  13. From the Summary drop-down list, select the output that produces the date and time the report was executed.

  14. Double click the entry to be taken to Data View.

  15. The Intensity field becomes the current field. Verify that Intensity has a value of 4 with the query count '2' displaying on the field widget and the field is blue. Continue tabbing through the fields until the field Is This A Serious Event? has the focus. Confirm that the 'No' box is marked for this field.

  16. Return back to the Intensity field by using Shift + Tab keys. With the focus on Intensity, examine the details in the Query window, and confirm that the batch edit check with the problem type Monitor has been added to this field.

    [Note]Note

    The query list is represented in accordance with the query sort order defined in Step 1.

  17. Double-click Site 99 - Hospital #99 entry to close all subject binders.

9.10. Use a data expression to retrieve specific subject information.

  1. Still in Data View, determine which subjects have had adverse events. Do this by selecting Select > By Data Fields from the menubar to open the Select by Data Fields window. In the dialog, set:

    • Mode = View

    • Plate = 5

    • Level = 1-4

    Do not select any Status box.

  2. Click Expression ... to open the Expression Editor dialog.

  3. Do the following to build an expression that searches for the occurrence of adverse events: From the Field list in the Expression Editor, select 25:AEYN from Fields. From the Symbols list choose == equals. From the Codes list choose 2 Yes. Click OK to add the expression to the Expression field in the Select by Data Fields retrieval dialog.

  4. Click Done to apply the settings. Click OK in the confirmation dialog to retrieve the 1 data record that matches the expression and retrieval criteria.

  5. Scroll down the current page for Subject 99001 to locate the adverse event question. Confirm that the Yes choice has been entered in response to the question Did the patient report any adverse events since the last visit?.

  6. Confirm that a corresponding adverse event report has been submitted for Subject 99001. Do this by clicking Show All Records for This Subject located below the subject binder list. Scroll through the list of assessments until the 1011 : Adverse Event 1 Page 1 entry is located. Select page entry for 9: Form 9, AE Report 011.

9.11. Use cross-plate data criteria to retrieve specific subject information.

  1. Select Select > All Records to release all task records from the previous test. Click OK in the resulting confirmation dialog. Select Select > By Data Fields from the menubar to open the Select by Data Fields dialog, click Clear to clear the previous retrieval specifications and reset the dialog.

  2. The test steps that follow will search for and retrieve all patients in the database that are >=50 years old, male and have a history of diabetes. Within the Select by Data Fields dialog, click ... next to the Subject field to open the Subjects dialog and then choose ALL as the value for Select subjects that match.

  3. Begin by building an expression for the first subject criterion of Age. Working in the Criterion #1 block, specify Visit = 0. Click ... next to the Plate label to open a list of study plates. In the list double-click entry 001 - Blood Pressure Screening Visits to populate the Plate field (plate 1 contains the Age data field). Click ... next to the Field field to get a listing of all fields defined on the selected plate 1. Double-click entry AGE to populate the Field specification. Using the Condition drop-down menu, choose >= greater than or equal to assign a retrieval Condition. Finally, specify 50 in Value as a search value.

  4. Click Retrieve to retrieve the number of subjects that match the specified Age criterion. Click Add to add a new criterion block in preparation for the specification of the 2nd retrieval criterion (Male).

  5. Build an expression for the second subject criterion of Male. Working in the Criterion #2 block, specify Visit = 0. Click ... next to the Plate label to open a list of study plates. In the list double-click entry 001 - Blood Pressure Screening Visits to populate the Plate field (plate 1 contains the Sex data field). Click ... next to Field to get a listing of all fields defined on plate 1. Double-click entry SEX to populate the Field specification. Using the Condition drop-down menu, choose == equal to assign a retrieval Condition. Select 1 Male from the Value pull-down.

  6. Click Retrieve to retrieve the number of subjects that match the specified Sex criteria. Click Add to add a new criteria block in preparation for the specification of the 3rd retrieval criteria (history of diabetes).

  7. Build an expression for the third subject criterion of diabetes history. Working in the Criterion #3 block, specify Visit = 1. Click ... next to the Plate label to open a list of study plates. In the list double-click entry 003 - Medical History to populate Plate (plate 3 contains the Diabetes data field). Click ... next to Field to get a listing of all fields defined on the selected plate 3. Double-click entry MHOCCUR (7. Diabetes: N/Y) to populate the Field specification. Using the Condition drop-down menu, choose == equal to assign a retrieval Condition. Select 2 Yes from the Value pull-down.

  8. Click Retrieve to retrieve the number of subjects that match the specified Diabetes history criteria. Click Done to find the subjects that match ALL three of the criteria specifications and close the Subject Criteria dialog.

  9. In the Select by Data Fields dialog, set:

    • Mode = View

    • Plate = 1,3

    • Level = 1-7

    to retrieve only those plates having the Age, Sex and Diabetes history information for the matching subjects.

  10. Click Done in the dialog to apply the settings. Click OK in the confirmation dialog to retrieve the 2 data records that match the subject, plate and level specifications.

  11. With 0 : Screening Visits, 1 : Form 1 for Subject 99004 as the active page, locate the Age and Sex fields. Confirm that the subject's Age >= 50 and Sex=male.

  12. Select 1: Baseline, 3: Form 3 for Subject 99004 to open the Medical History page. Scroll down the page to locate the 7. Diabetes field. Confirm that this field is checked 'Yes'.

  13. Select File > Exit from the menubar to close Data View and exit DFexplore.

9.12. End Module 9.

  • Return to the DFATK application. Click End to confirm successful completion of Module 9.

Chapter 10. Module 10: External Query Reports

10.1.  Tests & Requirements

  1. Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.

  2. Run database integrity check report DF_XXkeys to export all key fields and visit dates from required plates in the database.

  3. Use Data View to check and, if necessary correct, illegal visit dates by retrieving the problems keys identified by DF_XXkeys.

  4. Execute DF_QCupdate to update the query database and lock all records for query report generation.

  5. Execute DF_QCreports to create a standard, 3-part external query report for a study site.

  6. Confirm the status of external queries following query report creation.

  7. Execute DF_QCstatus to verify that a new query report was created by listing all reports in the QC/NEW directory.

  8. Execute DF_QCview to display the newly created query report.

  9. Execute DF_QCprint to print the query report from the QC/NEW directory.

  10. Comparing several examples from the printed query report against their corresponding queries in the study database.

  11. Execute DF_QCfax to email the query report to a valid email account.

  12. Verify the status of the queries in the sent report.

Estimate of Time Required: 40 Minutes

10.2. Begin Module 10.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 10 followed by Begin to begin this module.

10.3. Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select View > Status. Examine the Queries table to view the status and count of all queries in the database.

  3. Open the Graphics section and select the toggle button for by status. Confirm the count of Pending and Outstanding queries.

  4. Select View > List. Select the Plates & Metadata tab.

  5. Click metadata - Queries from the plate list to display information about database queries.

  6. Select Select > Search from the menubar to specify a set of query search criteria. In the resulting search dialog, check (enable) the Usage = external, click Update to update the dialog with details and a count of external queries.

  7. Click Done to close the Search dialog.

10.4. Run database integrity check report DF_XXkeys to export all key fields and visit dates from required plates in the database.

  1. Select View > Reports to change from List View to Reports View.

  2. Double-click DFdiscover Reports then Legacy Reports list by clicking the >. Select the report name DF_XXkeys from the list. Click Explain to view a detailed description of the report. As options do not exist for this report, click Run to execute DF_XXkeys.

  3. In Step 2, DF_XXkeys detected an illegal visit date. As indicated by the message in the reports window, a data retrieval file called VDillegal.drf was created. This file contains the plate(s) on which the illegal visit date was detected, and can be reviewed and edited in DFexplore Data View. Click Close Report to close the report output window. Select View > Data to change to Data View.

10.5. Use Data View to check and, if necessary correct, illegal visit dates by retrieving the problems keys identified by DF_XXkeys.

  1. To review the data retrieval file created in Step 2, select Select > By Data Retrieval File. In the retrieval file dialog, set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check (enable) Enable edit checks

    • Select from file = study server

  2. To locate the data retrieval file VDillegal.drf, click ... next to Select from file option. In the file selection dialog, choose the file VDillegal.drf, then click OK.

  3. Click OK in the dialog. Click OK in the resulting confirmation dialog to retrieve all data records having illegal visit dates.

  4. Click anywhere in the page background to make it active for data entry. Starting with the Follow-up choice field, press Tab to advance to the Visit Date. The Visit Date value has been entered as 04/17/97 (an illegal date), rather than 04/07/97 as shown on the CRF image. Enter the correct date and press Tab to exit the field.

  5. As problems no longer exist on the corrected page, the page can be saved to the database with a status of Final. Click Final to save the page.

10.6. Execute DF_QCupdate to update the query database and lock all records for query report generation.

  1. Select Select > All Records, click OK Select View > Reports to return to Reports View. Again choose the report name DF_XXkeys from the list and click Run button. Confirm that the output no longer reports illegal visit dates.

  2. Choose DF_QCupdate from the list of Legacy reports and click Explain to view a report description. Do not enter any options in the Specify field and click Run to update the Query database.

  3. A user requires unrestricted permissions to execute DF_QCupdate. As user valid1 is restricted to database Modify and Write levels of 0-4 (as set in Chapter 1, Module 1: Installation and Initialization), it is not possible to execute DF_QCupdate successfully. Click File > Exit to close DFexplore.

  4. In order for valid1 to be able to successfully execute DF_QCupdate, the role permissions must be changed at the DFdiscover system level. Start DFadmin. Enter your server name as the value for DFdiscover Server, datafax in the Username field, and the value for Password assigned to datafax. Click Login.

  5. In DFadmin, select the Roles tab to open the Role definition window. Select 254 Acceptance Test Study from the list of studies.

  6. Select the role valid1 permissions from the Roles list. Click Permissions tab to open the permissions for editing.

  7. Change the Get Level from 0-4 to ALL, and the Modify and Write Level settings from 0-4 to 0-7. Select File > Save or click Save to apply and save the level changes.

  8. Select File > Exit to exit DFadmin.

  9. Start DFexplore and login to the 254 Acceptance Test Study as described in Section 10.3, “Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.” as user valid1.

  10. Select View > Reports.

  11. Double-click DFdiscover Reports, expand Legacy Reports by clicking >. Choose DF_QCupdate from the list of reports. Click Run to re-execute DF_QCupdate with the correct database permissions.

10.7. Execute DF_QCreports to create a standard, 3-part external query report for a study site.

  1. Choose DF_QCreports from the list of Legacy Reports and click Explain to view a report description.

  2. Do not enter any options in the Specify field so that a complete query report is generated. Click Run to execute DF_QCreports.

    [Note]Note

    DFdiscover report numbers are comprised of a site number followed by the date of report creation (as yy/mm/dd). The two are separated by a hyphen. Your Query report has been created for Site 99 and the date of creation is the date on which DF_QCreports was executed (i.e.today).

  3. To print the output displayed, select File > Print. In the Print dialog, the Printer Name field contains the name of your printer. Click Print. Keep this printout to reference the query report number in Section 10.12, “Comparing several examples from the printed query report against their corresponding queries in the study database.”. Click Close Report to close the report output window.

10.8. Confirm the status of external queries following query report creation.

  1. Select View > Status. Click Refresh to update the database counts. Examine the Queries table to view the status and count of all queries in the database.

    [Note]Note

    The counts in the Queries table have changed because the query database has been updated by the running of the report DF_QCupdate in Section 10.6, “Execute DF_QCupdate to update the query database and lock all records for query report generation.”. If applicable, DF_QCupdate will create new queries for missing pages and overdue assessments based on the study scheduling information present in the study visit map files.

  2. Select View > List.

  3. Click metadata - Queries to display information about database queries.

  4. Select Select > Search to specify a set of query search criteria. In the resulting search dialog, Select (enable) Usage = External and click Update to update the dialog with details and a count of external queries.

  5. Click Done to close the dialog.

10.9. Execute DF_QCstatus to verify that a new query report was created by listing all reports in the QC/NEW directory.

  1. Select View > Reports.

  2. From the list of Legacy Reports, select DF_QCstatus and click Explain to view a report description. As a query report was created but not sent, click Run to obtain the status of all query reports currently in the study QC/NEW directory.

  3. Click Close Report to close the report output window.

10.10. Execute DF_QCview to display the newly created query report.

  1. To display the query report created for Site 099 - Hospital #99, choose DF_QCview. Click Explain to view a description of the report. As the report for Site 099 - Hospital #99 still resides in the QC/NEW directory (it has not yet been sent to the site), click Run to execute DF_QCview.

  2. Click Close Report to close the report output window.

10.11. Execute DF_QCprint to print the query report from the QC/NEW directory.

  1. Print a copy of the query report for Site 099 - Hospital #99 by choosing DF_QCprint. Click Explain to view a description of the report. Enter -u number of your query report in the Specify field, to print the newly created, but unsent report. Click Run to execute DF_QCprint.

    [Note]Note

    If you do not have a printer connected to the DFdiscover server or if you are a hosted client, the query report will not be printed. Instead you can choose to print the query report displayed in the DF_QCview output window from the previous Step 1.

  2. Click Close Report to close the report output window.

10.12. Comparing several examples from the printed query report against their corresponding queries in the study database.

[Note]Note

For this test you will need to reference the query report printed in Section 10.11, “Execute DF_QCprint to print the query report from the QC/NEW directory.” to verify the information contained in the report against the study database. Three examples of queries will be verified in this test. You may choose to check the remainder of the notes yourself.

  1. In the printed query report, find the entries for patients 99002 and 99004 in the FAX/REFAX section of the report. For patient 99002, locate the entry for Form 9, AE Report 011 having multiple queries in the Intensity field. For Patient 99004, locate the entry for Form Number 4, Pg 1 having the problem “Missing Page”. Form 4 corresponds to Plate 4 in the database. Now locate the entry for Form Number 2, having the problem “Pulse beats/minute (Missing)”. Form 2 corresponds to Plate 2 in the database.

  2. Select View > Data.

  3. Select Select > By Data Fields. In the dialog, set:

    • Mode = View.

    • Subject = 99002,99004

    • Plate = 2,4,9

    • Level = 1-7

  4. Click Done then OK to apply the record selection criteria and retrieve the applicable pages.

  5. Highlight the 9: Form 9, AE Report 011 page in the page list. Press Tab to advance through the fields until the Intensity becomes the current field. Confirm that this field is blue and the QC count “2” is displayed on the field widget. Examine the Query window to view the details of the queries. Verify that the information in the Query window is consistent with the corresponding printed Query report.

  6. In the record list, double-click entry for subject 99004.

  7. Press Tab to advance to the Pulse field to make it the current field. Verify that the field is blue (indicating that an outstanding query exists). Examine the Query to view the details of the query.

  8. Examine the record list for an entry for Form 4 for Subject 99004 (identified as a Missing Page on the query report).

  9. Select Select > All Records. Confirm the settings:

    • Mode = Modify

    • Save level= 1 - Level 1

    • Enable (check) edit checks

    Click OK to release the task set and display all records in the database.

10.13. Execute DF_QCfax to email the query report to a valid email account.

  1. Select View > Reports.

  2. Choose DF_QCfax and click Explain to view a description of the report. Send the query report generated in Section 10.7, “Execute DF_QCreports to create a standard, 3-part external query report for a study site.” to a valid email address. Enter -f mailto:user@localhost in the Specify field, substituting “user@localhost” with your email address as defined on your mail system. Click Run to execute DF_QCfax..

  3. Wait for several minutes, then check the recipient's email account for the arrival of the query report emailed in Step 2. Once the report has arrived, click Close Report to close the report output window.

10.14. Verify the status of the queries in the sent report.

  1. Select View > Status. Click Refresh to update the database counts. Examine the Queries table to view the status and count of all queries in the database.

    [Note]Note

    The counts in the Queries table are the same as those in Step 1 because queries have been sent to the site but not resolved.

  2. Select View > List, click Plates & Metadata.

  3. Select File > Preferences. Click List View to expand and click Label for Display coded field as, click OK. To display information about database queries, click metadata - Queries.

  4. Select Select > Search to specify a set of query search criteria. In the resulting search dialog, select (enable) Usage = external. Click Update to update the dialog with details and a count of external queries.

  5. Click Done to close the Search dialog.

  6. Select File > Exit to close and exit DFexplore.

10.15. End Module 10.

  • Return to the DFATK application. Click End to confirm successful completion of Module 10.

Chapter 11. Module 11: Replying to EDC Queries, eSignatures

11.1.  Tests & Requirements

  1. Determine a count of outstanding/outstanding queries in Status View.

  2. Review outstanding queries in Queries View.

  3. Using EDC, locate and reply to outstanding clarification queries.

  4. Add an Electronic Signature (eSign) to a set of completed subject records.

Estimate of Time Required: 30 Minutes

11.2. Begin Module 11.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 11 followed by Begin to begin this module.

  3. Click Send ID 99003 to email a copy of ID99003_module11.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

11.3. Determine a count of outstanding/outstanding queries in Status View.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select 254 Acceptance Test Study, click Continue to open its database.

  3. 1 Case report form page for Subject 99003 arrives on your local printer or via email to the address provided in Step 5. Alternatively a copy of the Subject 99003 CRF can be obtained from the back of the Acceptance Test Study manual. You will need to reference this page in several of the tests in this module.

  4. Select View > Status. Examine the Queries table to view the status and count of all queries in the database.

  5. Locate the Outstanding column that displays a count of 17. Double-click number 17 to retrieve the records containing the 17 outstanding queries.

  6. In the Database Status task Specification dialog set:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Check (enable) Enable Edit checks

    • Search queries and open check (enable) Queries View?

    Click Yes to display a dialog confirming the retrieval. In the confirmation dialog, click OK to open Queries View.

11.4. Review outstanding queries in Queries View.

  1. Select Show > Outstanding Queries to verify that you are seeing only outstanding queries for subjects in Site 99 - Hospital #99.

  2. Examine Queries View to confirm :

    • The Status & Replies column displays Outstanding (New, in report and sent) for all queries.

    • An entry exists for Subject 99001, Screening Visits Form 1, 5. Patient has signed informed consent.

    • An entry exists for Subject 99007, Screening Visits Form 1, Screen 1 Reading 1 systolic.

11.5. Using EDC, locate and reply to outstanding clarification queries.

  1. Locate the entry for Subject 99001, Screening Visits Form 1, 5. Patient has signed informed consent. Double-click the query to switch to Data View and make the queried page and field active. Examine the information present in the Query window.

  2. Select Field > Reply to Query or click . In the dialog, enter Informed consent was sent to study coordinator by email on March 20. in the New Reply field.

  3. Click OK to apply the reply to the queried field. Examine the information present in the Query window.

  4. Do not enter or change data in any of the remaining fields on the current page. Click Final to save the current page and the query reply to the database.

  5. From the record list window, click Return to Queries View. Examine the list of queries.

  6. Locate the entry for Subject 99007, Screening Visits: Form 1, Screen 1: Reading 1 systolic. Double-click systolic blood pressure query to switch to Data View and make the queried page and field active. Examine the information present in the Query window.

  7. Select Field > Reply to Query or click in the dialog, enter Systolic reading was entered incorrectly. It should be 170. in the New Reply field.

  8. Click OK in the Reply to Query dialog to apply the reply to the queried field. Examine the information present in the Query window.

  9. Click Final to save the current page and the query reply to the database.

  10. Select File > Exit to close and exit DFexplore.

11.6. Add an Electronic Signature (eSign) to a set of completed subject records.

[Note]Note

eSignatures require password permission to be set in the user role at the DFadmin level. The Password permission must be granted for the specific eSignature plate.

  1. As user datafax open the login dialog for DFadmin as described in (Section 1.5, “Define Acceptance Test Study to the DFdiscover server.”). Enter the login name and password for user datafax and select Login. Click Login to login.

  2. In DFadmin, click Roles tab to open the Role definition window. Choose the entry for 254 Acceptance Test Study from the list of studies.

  3. Choose the role valid1 permissions from the roles list. Select Permissions tab to open the permissions for editing.

  4. Modify the existing row of permissions by replacing Plates ALL with 1-6,8-200 as shown below. As the Study Termination plate (plate 7) collects eSignatures, specify permissions for plate 7 as a second permission row as shown below.

  5. Select File > Save or click Save to apply and save the modifications to the role. Select File > Exit to exit DFadmin.

  6. Start DFexplore and login as valid1 to and open the 254 Acceptance Test Study as described in (Section 11.3, “Determine a count of outstanding/outstanding queries in Status View.”)

    [Note]Note

    Locate the page for Subject 99003, plate 7, Study Termination that was printed when the module was started. You will need this page for the next series of test steps.

  7. Double-click Site 99 - hostpital #99. Locate subject 99003, double-click its entry to expand a list of assessments for Subject 99003.

  8. Double-click 30 : Study Termination. Select 7: Form 7 to open a new study termination form.

  9. Click anywhere in the screen background to begin data entry. Press Tab to advance to the Patient Number field. Using the printed form for Subject 99003, enter all field values up to and including the 2. Last dose of study medication - Unknown question.

  10. Press Tab to advance to the Investigator's Signature field. This field and the remaining fields on the page are used to capture eSignature name, date and time, respectively. Attempt to enter any name in the Investigator's Signature field.

  11. Press Tab to advance to the remaining 2 eSignature fields. Again attempt to manually enter data into each of these fields. Press Tab to exit the last field on the page (eSignature time) to make the save buttons active.

  12. Click Final to save and eSign the Study Termination form.

  13. In the dfpassword confirmation dialog enter the user name valid1 and the corresponding password used for login in Section 11.6, “Add an Electronic Signature (eSign) to a set of completed subject records.”. Click Sign to apply the electronic signature to the current Study Termination page.

  14. Return to the signed Study Termination form by selecting the 7: Form 7 entry for Subject 99003. Examine the 3 eSignature fields at the bottom of the page.

  15. Select File > Exit to close and exit DFexplore.

11.7. End Module 11.

  • Return to the DFATK application. Click End to confirm successful completion of Module 11.

Chapter 12. Module 12: Re-submitting CRFs and Correcting Queries

12.1. Tests & Requirements

  1. Submit PDF images to DFexplore.

  2. Verify that all CRFs have arrived successfully in Image view.

  3. Retrieve submitted CRFs using DFexplore Image View.

  4. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.

  5. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.

  6. Enter Form 4, Subject 99004.

  7. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.

  8. Select and resolve a query in a field that has multiple queries.

  9. Review and approve a pending query reply for Form 1 for Subject 99002.

  10. Review, correct and approve a pending query reply for Form 1, Subject 99007.

  11. Confirm query resolution by examining the database status.

Estimate of Time Required: 30 Minutes

12.2. Begin Module 12.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 12 followed by Begin to begin this module.

12.3. Submit PDF images to DFexplore.

  1. Click Send Query Corrections to email a copy of QC_corrections.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Save the QC_corrections.pdf file received via email to your local computer. This file is required to complete the remainder of this module. Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

  2. Start DFsend as described in Section 1.8, “How to start DFsend.

  3. Click Add. From the Select PDF Files file selection dialog, locate the previously saved QC_corrections.pdf file. Select the file, Click Open.

    [Note]Note

    Alternatively documents can also be added by dragging-and-dropping the desired PDF files from a local file folder directly into the list area.

  4. Click Send, enter valid1 in the Username field and the previously assigned password in the Password field. Click OK.

  5. In the resulting Send PDFs to DFdiscover dialog, confirm 1 success and 0 failure are shown. Click OK.

  6. Click Show Log to confirm successfull transmission of the QC_corrections.pdf file to DFexplore.

  7. Select File > Exit.

    [Note]Note

    Wait 2-3 minutes prior to proceeding to DFexplore.

12.4. Verify that all CRFs have arrived successfully in Image view.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select File > Preferences. In the Preferences dialog, click from Image View section. Select (enable) When the revised record is saved for the duplicate resolution setting. Click OK to save and close the Preferences dialog.

  3. Select View > Status. Examine the information displayed for the Image Queue, Data and Queries tables.

    [Note]Note

    The number of pages awaiting review in the Image Router may be different from that shown here as this number includes pages for all studies on the DFdiscover server, not only those that belong to the 254 Acceptance Test Study.

12.5. Retrieve submitted CRFs using DFexplore Image View.

  1. Select View > Image, in the resulting Automatic Retrieval dialog set:

    • Check (enable) Enable Edit Checks

    • Save level = 1 - Level 1

    • Select = document

    • By Age = oldest

    • Quantity = 25

  2. Click OK to bring forward all new images awaiting data entry.

12.6. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.

  1. With the Patient Entry Form for Subject 99001 as the current page, click anywhere on the page background to make the page active for data entry. Beginning with the Patient Number field, verify that the correct Subject 99001 is displayed. If the Patient Number is incorrect, correct it and press Tab to exit the field.

    [Note]Note

    In your normal image entry process, you must always pay careful attention to the accuracy of the ICR data. You will need to do the same here. It is possible that the new pages contain ICR errors that you will need to correct during entry. In particular, it is important that you correct any key fields (visit and/or patient numbers) that may have been mis-read as these are critical to the identification and storage of the data. Note that the ICR data records on your screen may not match exactly those shown in the examples throughout this module.

  2. Click OK to load the data from the existing Subject 99001, Patient Entry Form.

  3. Press Tab to advance from field to field, and verify that data is the same as that found on the CRF image. Note that some fields may contain values that have been assigned by edit checks. Stop when the Smoking Status field becomes the current field. Examine the details in the Query window. Enter the data as it appears on the image.

    [Note]Note

    When data is entered into a field that contains an outstanding missing value query of type Correction, the query is automatically resolved by DFdiscover as the missing data has now been provided. The color green indicates that the query has been resolved.

  4. Continue tabbing through the remaining fields on the page to verify that the data in the fields is the same as the CRF image. Once the save buttons become active at the bottom of the record, click Final to save the corrected page to the database.

  5. Using the scroll bars, examine the primary image and locate the corrected Smoking Status field to verify that this is the same image that was saved with the corrected data record in Section 12.6, “Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.”. Click Cancel to exit the Review Images dialog.

  6. Return to the saved page for Subject 99001 by selecting it from the Image queue list. Examine the bottom right corner of the main data entry screen.

12.7. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.

  1. From the new image queue list, click the 2nd entry in the list (Subject 99002) to make it the current page. Click anywhere on the page background to make the page active for data entry. Beginning with the Patient Number field, enter the correct subject 99002 and press Tab to exit the field.

  2. Click OK to load the data from the existing Subject 99002, Patient Entry Form.

  3. Press Tab to advance from field to field, and verify that data is the same as that found on the CRF image. Stop when the Date of Birth field becomes the current field. Examine the details in the Query window.

  4. Enter the corrected date value as it appears on the image of the CRF 05/12/51. With Date of Birth as the current field, select Field > Edit Query or click the .

  5. Select Resolved corrected from the Status pull-down. Click OK to apply the change to the query status. Examine the Query window.

  6. Continue tabbing through the remaining fields on the page to verify that the data in the fields is the same as the CRF image. Note that some fields may contain values assigned by edit checks. Once the save buttons at bottom of the record become active click Final to save the corrected page to the database.

  7. Using the scroll bars, examine the primary image and locate the corrected Date of Birth field to verify that this is the same image as was saved with the corrected data record in Section 12.7, “Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.”. Click Cancel to close the Review Images dialog.

12.8. Enter Form 4, Subject 99004.

  1. Click anywhere on the page background to make the page active for data entry. Beginning with the Medications Page Number field, enter 1 as shown on the CRF image. Press Tab to exit the field and move to the Patient Number. Enter the number shown on the CRF image and leave the field.

    [Note]Note

    The Current Medications form for Subject 99004 has been flagged as Missing in the Quality Control report of Module 10. As a result, arrival of this plate will not trigger the Duplicate Record warning because the page does not currently exist in the study database.

  2. Enter all fields on the data record as they appear on the CRF image. Once the save buttons at bottom of the record become active, click Final to save the entered page to the database.

    [Note]Note

    The Review Images window does not appear upon saving Form 4, Subject 99004 because a duplicate page does not exist in the database for this set of keys.

12.9. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.

  1. Click anywhere on the page background to make the page active for data entry. Beginning with the Patient Number, enter 99004 as shown on the CRF image. Press Tab to exit the field.

  2. Click OK to load the data from the existing Subject 99004, Patient Entry Form.

  3. Press Tab to advance from field to field, and verify that data is the same as that found on the CRF image. Note that some fields may contain values assigned by edit checks. Stop when the queried Pulse field becomes the current field. Examine the details in the Query window.

  4. Enter the correct response as it appears on the image of the corrected CRF. Examine the details in the Query window and press Tab to exit the corrected Pulse field.

  5. Continue tabbing through the remaining fields on the page to verify that the data in the fields is the same as the CRF image. Once the save buttons at the bottom become active, click Final to save the corrected page to the database.

  6. Using the scroll bars, examine the primary image and locate the corrected Pulse field to verify that this is the same image as was saved with the corrected data record in Step 3. Click Cancel to close the Review Images window.

12.10. Select and resolve a query in a field that has multiple queries.

  1. With the Adverse Event Report Form for Patient Number 99002 as the current plate, click anywhere on the page background to make the page active. Beginning with the Adverse Event Report No. field, enter the value as shown on the CRF image. Press Tab to exit this field and advance to the AE Identifier field. Upon entering the AE Identifier field, the edit check AESEQNUM2 automatically complete this field. Press Tab to exit the AE Identifier field to advance to the Patient Number field. Verify that the correct Subject 99002 is displayed for the Patient Number field. If the number is incorrect, correct it and press Tab to exit the field.

  2. Click OK to load the data from the existing Subject 99002, Adverse Event Report Form.

  3. Correctly enter each data field on the page per the CRF image, up to the Intensity field. Confirm that the Intensity field has a value of 4, and contains 2 unresolved queries.

  4. Enter the correct value 2 for Intensity field per the CRF image. Examine the details in the Query window.

  5. Select Field > Edit Query or click the . Choose Resolved corrected from the Status pull-down. Click OK to apply the edits.

  6. With the focus still on the Intensity field, examine the details in the Query window. Select the Clinical QC query from the Query drop-down, and examine its details.

  7. Select Field > Edit Query or click the in the dialog, choose Resolved corrected from the Status pull-down. Click OK to apply the edits.

  8. Press Tab to advance through the fields, and verify that the data is the same as that found on the CRF image. Note that upon leaving the Description field, the DrugLookup edit check is executed and DFlookup:aecodes dialog appears. Click Cancel to close the DFlookup:aecodes dialog.

  9. Continue tabbing through the remaining fields on the page and verify that the data in the fields is the same as the CRF image. Once the save buttons become active at the bottom of the record, click Incomplete to save the corrected page to the database. Upon clicking the Incomplete, the Review Images dialog appears. Click Cancel to close the Review Images window.

12.11. Review and approve a pending query reply for Form 1 for Subject 99002.

  1. Select View > Queries.

  2. Click OK in the confirmation dialog to release the Image View records and open Queries View.

  3. Select Show > Pending Queries to display only queries for which a resolution is pending. Double-click Site 99 - Hospital #99 entry to display all pending queries.

  4. Locate the pending query for Subject 99001, 5. Patient has signed informed consent. Double-click the query to make the queried field and page the current page. Examine the information in the Query window.

  5. Select Field > Approve Queries and Reasons to review all queries and reasons that are present on the current page.

  6. Choose Resolved corrected from the Status pull-down. Enter Signed informed consent was received March 20, 2009. in the Note field.

  7. Click Save to apply the Resolved corrected status to the query. Click Done to close the Approve Queries and Reasons dialog.

  8. Do not change any other data or meta data on the screening visits page for Subject 99001. Make the save buttons at the bottom of the screen active and click Final to save the data record and query to the database.

  9. In the record list window, click Return to Queries View to return to Queries View to process the pending query for Subject 99007.

12.12. Review, correct and approve a pending query reply for Form 1, Subject 99007.

  1. Locate the pending query for Subject 99007, Screen 1: Reading 1 systolic. Double-click the query to make the queried field and page current. Examine the information in the Query window.

  2. Select Field > Approve Queries and Reasons to review all queries and reasons that are present on the current page.

  3. Choose Resolved corrected from the Status pull-down.

  4. Click Save to apply the Resolved corrected status to the query. Click Done to close the Approve Queries and Reasons dialog.

  5. The query reply indicates that the systolic blood pressure value should be 170. With the focus still on the Screen 1: Reading 1 systolic field on the page, change the value to 170.

  6. Click Final to save the data record and query to the database.

  7. In the record list window, click Return to Queries View to return to Queries View.

12.13. Confirm query resolution by examining the database status.

  1. Select View > Status. Examine the information displayed for the Image Queue, Data and Queries tables.

  2. Select File > Exit to close Status View and exit DFexplore.

12.14. End Module 12.

  • Return to the DFATK application. Click End to confirm successful completion of Module 12.

Chapter 13. Module 13: Data Export and DFsas

13.1. Tests & Requirements

  1. Export date values from the database in calender format and save the exported data to a file on the local computer.

  2. Export date values from the database and save the exported data to a file on the local computer.

  3. Examining data values according to user-specified criteria.

  4. Query the database for specific data values.

  5. Create a DFsas job file according to user-specified criteria.

  6. Create a SAS job file and data files using the DFsas job file criteria.

  7. Compare the contents of SAS data files with the actual data in the database.

Estimate of Time Required: 30 Minutes

13.2. Begin Module 13.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 13 followed by Begin to begin this module.

  3. Click Send ID 99006 to email a copy of ID99006_diary.pdf to valid1. Clicking more than once will result in multiple pages arriving to your email inbox.

    [Note]Note

    Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

    Wait 2-3 minutes prior to proceeding to DFexplore.

13.3. Export date values from the database in calender format and save the exported data to a file on the local computer.

All data exported in the following tests will be output to the DFexplore List View screen rather than saved to a file. List View does have 3 save options: Export Data, Save Data Retrieval File and Save As PDF.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select View > List.

  3. Select File > Preferences. In the dialog, locate the List View panel. Click Enter the List View settings as follows:

    • Display field name as = alias

    • Display coded field as = label

    • Display date field as = calendar

    • Check (enable) apply imputation rule

    • Display missed code as = default

    • Check (enable) Fill cell with field color

    • Uncheck (disable) Expand text fields

  4. Click OK to close the dialog.

  5. In the main List View window, Plates & Metadata panel, click 011 - Weekly Patient Diary in the list of plates.

  6. Select Select > Field Selection to show the listing of all data fields and their metadata properties defined for the plate. In the Data Fields window, click next to fields 7:SUBJID011, 10:DDATE1, , 16:DDATE2 , 22:DDATE3 , 28:DDATE4 , 34:DDATE5 , 40:DDATE6 and 46:DDATE7. The fields are added to the Display Fields window.

    [Note]Note

    Alternatively fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

  7. Click Done to apply the field selection criteria and close the dialog.

  8. Examine each of the exported date fields. Locate the field column for DDATE1 in the table. This is field 10, 1. Date on the Weekly Patient Diary page. In Section 3.12, “Submit a copy of the newly setup Plate 11 into the study database and retrieve the page in DFexplore Image View.” this field was defined with the format dd/mm/yy (a 2-digit year). Verify that field 10 has been correctly exported in calendar (4-digit year) format.

  9. Double-click DDATE1 cell for ID 99006 in the table. This takes you to the corresponding date field in the Weekly Patient Diary page in Data View. Confirm that the date values are the same as those on the printed Weekly Patient Diary for Subject 99006.

  10. In the record list panel, click Return to List View to be taken back to the date fields in List View. Confirm that the date values displayed are the same as those on the printed Weekly Patient Diary, except now in calendar (4-digit year) format.

13.4. Export date values from the database and save the exported data to a file on the local computer.

  1. Select File > Preferences. In the List View panel, choose julian as the value of Display date field. Click OK to apply the settings and close the dialog. Confirm that the the exported date values are now in julian format.

  2. Select File > Export Data to save the dates to a local file. In the dialog, set:

    • Format = Excel

    • Check (enable) Include header as the first record in output file

    • Check (enable) Open output file after export

  3. Click ... next to Output File. Choose a directory in the file selection dialog, enter module13_dates.xlsx as the filename, and click Save. Click Save to create/write the file and close the dialog.

  4. Using the computer's file explorer, locate the file module13_dates.xlsx. Open the file, confirm the contents and then close the file.

13.5. Examining data values according to user-specified criteria.

  1. Return to List View. From the list of plates, select plate 001 - Blood Pressure Screening Visits to make it current.

  2. Select Select > Field Selection. In the Data Fields window, Click next to fields 7:SUBJID001, 8:PINIT001, 9:AGE , 10:SEX, the fields are added to the Display Fields window.

    [Note]Note

    Alternatively fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

  3. Click Done to apply the field selection criteria and close the dialog. Examine each of the data fields.

  4. To search for specific subject data, select Select > Search. Enter 99003 in the Subject field.

  5. Click Find to start the search. Examine the message in the bottom-left corner of the dialog as well as the highlighted entry in the List View table.

  6. Click Find Next to locate a 2nd match (if one exists) in the List View table.

  7. Click New Task to create a task set of records that match the search criteria. In the resulting dialog, change the Mode to View.

  8. Click Yes in the Data List dialog to create the task set. Examine the message in the bottom-left corner of the Search dialog, then click Done to close the dialog.

  9. Click Switch to Data View to open Data View and review the List View task record. Examine the Data View record list and confirm that only the task record for Subject 99003 is displayed. Click Return to List View.

13.6. Query the database for specific data values.

  1. Select File > Preferences. In the dialog, locate the List View panel. Choose default for Display date field. Click OK to save the setting and close the dialog.

  2. Click 007 - Study Termination to make it the current page. Select Select > Search to open the Search dialog opens.

  3. Click Reset and Reset in the resulting dialoag to clear all previously specified search criteria.

  4. Click ... next to the Expression field. The Expression Editor dialog opens.

  5. For the first part of the query, select 9:FINALDAT from the Fields table. Next, click >= in the Symbols list. Choose julian from the Functions list. In the Expression field, enter the date "1997/01/01" (including the quotes). Close the parentheses. To build the second part of the query, click && From the Symbols list, followed by field 9:FINALDAT from the Fields table. Next, click <= in the Symbols list. Choose julian from the Functions list. In the Expression field, enter the date "1997/06/30" (including the quotes). Close the parentheses. Click OK.

  6. Click Find to locate all subjects that have study termination dates that match the specified search expression.

  7. Click Find Next to locate the next match.

  8. Do not continue the search and click Done to close the Search dialog.

13.7. Create a DFsas job file according to user-specified criteria.

  1. Select File > DFsas. The DFsas dialog opens.

    [Note]Note

    If you have previously executed this module as valid1, the DFsas Jobs panel may display jobfile1 and possibly other files. If jobfile1 is already in the list, highlight jobfile1 and click Delete before continuing with this module.

  2. Click Add to create a new DFsas job.

  3. Enter SASJOB = jobfile1. Click RUNDIR ... to display the system file selection dialog. Choose a directory to the save "jobfile1" and click Open.

    [Note]Note

    The RUNDIR directory was specified as C:\Users\valid1\Desktop in this example. Given the directory structure on your local computer, you may have chosen a different value for RUNDIR.

  4. Click PLATES ... to view all defined study plates. From the list, hold Control key (hold Command on macOS) and click the entries for 002 - Patient Entry Form and 009 - Adverse Event Report to highlight them. Click OK. Choose FIELDS = include all.

  5. In the Optional panel set:

    • Check (enable) only calendar for Date Formats

    • String Size = as is

    • Field = use alias

    Click OK to create and add jobfile1.

  6. Click OK in the summary confirmation dialog.

  7. Edit the SUBJECTS global specification in the new jobfile1 by selecting it from DFsas Jobs panel. In the main window, change the text SUBJECTS all to SUBJECTS 99001,99002. This will limit the created SAS data files to subjects 99001 and 99002 only.

  8. Locate the global specifications for CHECK and CHOICE. Change CHECK codes to CHECK labels and CHOICE codes to CHOICE labels.

  9. Click Save to save the changes. In the resulting confirmation dialog, choose replace existing job and click OK.

13.8. Create a SAS job file and data files using the DFsas job file criteria.

  1. In the DFsas window, highlight jobfile1. Click Run to create SAS job and data files.

  2. In the confirmation dialog, do not check Force DFsas to include all specified plates. The SAS job and data files will not include empty plates. Click Yes to continue and run the DFsas job. After a pause while the job runs, the results dialog appears. Click OK to close the dialog.

  3. Using the operating system file explorer, locate the directory previously specified as the value of RUNDIR. Confirm that jobfile1.zip is present. Double-click jobfile1.zip to unzip the file. Open the jobfile1 folder and confirm that the files jobfile1, jobfile1.sas, jobfile1.d01 and jobfile1.d02 are present.

  4. With a text editor application, open the data file jobfile1.d01. Examine the contents and confirm that it contains 2 data records - one for each of subjects 99001 and 99002. Print the file (you will need to reference this printed output in Section 13.9, “Compare the contents of SAS data files with the actual data in the database.”) and then close the text editor application.

  5. With the same text editor application, open the data file jobfile1.d02. Examine the contents and confirm that it contains 1 data record. Print the file (you will need to reference this printed output in Section 13.9, “Compare the contents of SAS data files with the actual data in the database.”) and then close the text editor application.

13.9. Compare the contents of SAS data files with the actual data in the database.

  1. Click Cancel to dismiss the DFsas dialog. Select Select > All Records. Without changing any settings, click OK.

  2. Select View > Data to change from List View to Data View. In the record list, double-click icon for the open Subject 99003 to close the subject binder. The list now displays all subjects for Site 99 - Hospital #99.

  3. Double-click Subject 99001. Select Subject > Expand All Visits. Locate the entry for 2: Form 2 within the 1 : Baseline visit and select it from the list to open the data record.

  4. Compare the values in each field of the data record in DFexplore with those values in the printout of the data file jobfile1.d01.

  5. Double-click Subject 99002 from the record list. Select Subject > Expand All Visits. Locate the entry for 2: Form 2 within the 1 : Baseline visit and select it from the list to open the data record.

  6. Beginning with Subject 99002, Baseline, Form 2, compare the values in each field of the data record in DFexplore with those values in the printout of the data file jobfile1.d01.

  7. Double-click Subject 99001 to re-open the subject binder. Select Subject > Expand All Visits. Locate the entry for 9: form 9, AE Report 011 within the 1011: Adverse Event 1 Page 1 visit and select it from the list to open the data record.

  8. Compare the values in each field of the data record in DFexplore with those values in the printout of the data file jobfile1.d02.

  9. Select File > Exit to close DFexplore

13.10. End Module 13.

  • Return to the DFATK application. Click End to confirm successful completion of Module 13.

Chapter 14. Module 14: PDF File Creation

14.1. Tests & Requirements

  1. Retrieving existing data according to user-specified criteria.

  2. Saving DFexplore data to a standard PDF document.

  3. Viewing a standard PDF data file using a PDF viewer application.

  4. Saving DFexplore data to an encrypted bookmarked PDF file.

  5. Open and view an encrypted bookmarked PDF file using a PDF viewer application.

  6. Create a complete subject package PDF file that includes data records, CRF images and an audit trail.

  7. Open and view a PDF subject package using a PDF viewer application.

Estimate of Time Required: 30 Minutes

14.2. Begin Module 14.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 14 followed by Begin to begin this module.

14.3. Retrieving existing data according to user-specified criteria.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select Select > By Data Fields. Set retrieval criteria as follows:

    • Mode = Validate

    • Save level = 1 - Level 1

    • Search = Data

    • Subject = 99001,99002

    • Level = 1-4

  3. Click Build Set to retrieve all data records that match the specified criteria. Click OK in the confirmation dialog, and finally click Done to create a task set of the retrieved data.

  4. Scroll the record list panel to confirm that 2 subjects, 99001 and 99002, have been retrieved. Double-click the entry for Subject 99002 to open and lock all records for the subject.

14.4. Saving DFexplore data to a standard PDF document.

  1. Select File > Save as PDF.

  2. In the Selection Criteria panel,

    • Select (enable) Data and images followed by current task set

    In the Save Options panel,

    • Check (enable) Data records and data + primary image (side by side)

    • Check (enable) Apply field color for completed plates

  3. Click Output File .... In the file selection dialog, choose a directory in which to save the PDF file.

    Once a directory has been chosen, append the file name subjects.pdf to the directory name. Click Save.

  4. Complete the specification by clicking Save. There will be a busy pause while the PDF file of completed data pages and their primary images is created.

    [Note]Note

    The save directory in this test was chosen to be C:\Users\valid1\Desktop. Your save directory may be different.

14.5. Viewing a standard PDF data file using a PDF viewer application.

  1. A PDF viewer application, such as Acrobat Reader, is required for this step. Start the PDF viewer application. Locate the directory in which the PDF file subjects.pdf was saved in Section 14.4, “Saving DFexplore data to a standard PDF document.”. Open subjects.pdf.

    [Note]Note

    All PDF files opened in this test and in the remainder of this module are illustrated using Acrobat Reader. If you are using a different PDF viewer application, the appearance of your document may differ from that shown here. It may also be necessary to rotate the PDF image so that it is displayed in landscape format.

  2. Examine the PDF document.

  3. Exit the PDF viewer application.

14.6. Saving DFexplore data to an encrypted bookmarked PDF file.

  1. With the task set of records from Section 14.3, “Retrieving existing data according to user-specified criteria.” (Subjects 99001 and 99002) still the current set, click the record for Subject 99002, Form 1 to set it as the current page. Select File > Save As Bookmarked PDF to open the dialog.

  2. In the Selection Criteria panel,

    • Select (enable) Current subject

    In the Resources panel,

    • Enter a Title of Bookmarked Subject 99002

    • Use the default Nesting plates within visits

    In the PDF Options panel,

    • Check (enable) Data records

    • Check (enable) Missed records

    • Check (enable) Images and select (enable) primary only

    • Check (enable) Apply field color for data records

    In the PDF Output panel,

    • Select an Output File directory using the file selection dialog and set the file name to subject99002.pdf.

  3. Enter module14 as the value for Password.

  4. Click Save to create a password encrypted PDF file of completed data pages and primary images for Subject 99002.

  5. Click OK to close the dialog.

14.7. Open and view an encrypted bookmarked PDF file using a PDF viewer application.

  1. A PDF viewer application is required for this test. Start the PDF viewer application. Locate the directory created in Section 14.6, “Saving DFexplore data to an encrypted bookmarked PDF file.”. Locate and open subject99002.pdf.

  2. In the Password dialog enter module14 as the password. This matches the password that was specified at file creation in Section 14.6, “Saving DFexplore data to an encrypted bookmarked PDF file.”. Once the password has been entered, the PDF file opens.

  3. Open all bookmarks for Subject 99002.

  4. In the bookmark panel, each data record is represented by the suffix (data) to distinguish it from the primary CRF image. Click entry Form 2 (data) to make the Form 2 data record the active page. Click entry Form 2 to make the Form 2 primary CRF image the active page.

  5. Exit the PDF viewer application. In DFexplore, select View > Data. Then, select Select > All Records. This will release the task set of records for Subjects 99001 and 99002. Click OK in the resulting dialog to retain the default settings.

14.8. Create a complete subject package PDF file that includes data records, CRF images and an audit trail.

  1. Select File > Create Subject Packages.

  2. In the Subject Selection section, choose Subjects from the drop-down and enter 99001,99002,99003 to create complete subject packages for Subjects 99001, 99002 and 99003.

  3. In the remainder of the dialog specify the following settings:

    • Title = Site 99 Subject Packages

    • Check (enable) Data records

    • Check (enable) Missed records

    • Check (enable) Images

    • Check (enable) primary only

    • Check (enable) Include data and metadata change history

    • Check (enable) Apply field color for data records

  4. Specify a PDF output folder by first clicking the Output folder ... to view the directory structure for the local computer on which user valid1 is working. Select a directory in which to save the subject package PDF files. Click Select Folder.

  5. Specify a file prefix to be prepended to each subject package created. Enter Site99_ in the File prefix field.

  6. Do not encrypt the subject packages to be generated by leaving the Password field empty. Click Start to begin generating a complete subject package for each of the specified subjects 99001, 99002 and 99003.

  7. Verify that the output in the confirmation dialog specifies packages for subjects 99001, 99002 and 99003. Click Start to start package creation.

  8. In the confirmation dialog, click View Log. Review the output. Click OK to close the log.

  9. The main Create Subject Packages dialog is displayed. Click Cancel to close this dialog.

14.9. Open and view a PDF subject package using a PDF viewer application.

  1. A PDF viewer application is required for this test. Start the PDF viewer program. Locate and open the directory in which the PDF subject packages were saved in Step 7. Locate files “Site99_99001.pdf”, “Site99_99002.pdf” and “Site99_99003.pdf”.

  2. Open the subject package for Site99_99001.pdf.

  3. Open all bookmarks for Subject 99001.

  4. In the record list, each data record is represented by the term (data) to distinguish it from its primary CRF image. Click entry Form 2 (data) to make the Form 2 data record the active page. Click entry Form 2 to make the Form 2 primary CRF image the active page.

  5. In the bookmark list click entry for Data and Metadata Change History to display the complete audit trail report for Subject 99001.

  6. Exit the PDF viewer application to close both the file “Site99_99001.pdf” and PDF viewer.

  7. Select File > Exit to close and exit DFexplore.

14.10. End Module 14.

  • Return to the DFATK application. Click End to confirm successful completion of Module 14.

Chapter 15. Module 15: eCRF Creation for DFdiscover

15.1. Tests & Requirements

  1. eCRF creation in DFsetup.

  2. eCRF background color preferences.

  3. Entering eCRF data in DFexplore.

Estimate of Time Required: 20 Minutes

15.2. Introduction

This module utilizes the use of Electronic case report forms (eCRFs) which you will create within DFsetup without needing to import a PostScript® or PDF file containing the form background image. eCRFs do not contain barcodes and are therefore only suitable for entry via EDC.

15.3. Begin Module 15.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 15 followed by Begin to begin this module.

  3. This module requires user valid1 to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

15.4. eCRF creation in DFsetup.

  1. Start DFsetup and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  2. Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

    [Note]Note

    The main DFsetup window displays the last plate to be active in the user's previous DFsetup session. For this reason, you may see a different plate from what is displayed in the above illustration.

  3. Select Study > Add eCRF Plate... in the DFsetup - Add eCRF Plate dialog enter a New Plate Number of 21. Click OK.

  4. In the Plate Properties set:

    • Label = Lab Results

    • eCRF = Yes

    • Sequence is = predefined

    • Triggers Early Termination = No

    • Eligible for Signing When = Final

    Click Apply.

  5. Within Plates-Modules-Fields Module options Click Add, Check Keys, LB, LB1, LB2, LB3 modules, click OK.

  6. Double-click Keys [1] module to expand the list of fields. Using your mouse, click and drag the SUBJID and PINIT fields onto the 21: Lab Results eCRF.

  7. Click LB [1] Module, drag the module onto the eCRF, select LBORRES_n, LBNRIND and LBCLSIG_c fields by holding Shift and clicking on the fields. Select Field > Group.

  8. Click LB1 [1] Module, drag the module onto the 21: Lab Results eCRF. Select Field > Group.

  9. Click LB2 [1] Module, drag the module onto the 21: Lab Results eCRF. Select Field > Group.

  10. Click LB3 [1] Module, drag the module onto the 21: Lab Results eCRF. Select Field > Group.

  11. Select File > Save.

  12. Select File > Exit to close DFsetup.

15.5. eCRF background color preferences.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Click Site 99 - Hospital #99 > Subject 99008 > 1: Baseline > 21: Lab Results to make it the active page.

    [Note]Note

    DFexplore stores previously defined user preferences. If valid1 previously used DFexplore and modified user preferences. You may see a different background than what is illustrated below.

  3. Select File > Preferences, click Background Options to expand the preferences. Click Color > OK to apply the changes.

  4. Select File > Preferences > Data Window, within eCRF background color, click to open the Select Color window.

  5. set HTML:#66EEEE.

  6. Click OK to close the Select Color window, click OK to apply your color preferences.

15.6. Entering eCRF data in DFexplore.

  1. Click within the Patient Initials field to display the field level help. Click to close the help dialog.

  2. With subject 99008 21: Lab Results still as the current eCRF. Click Patient Initials the initials automatically occupy this field as a result of the edit check SetInit described in Module 5: Image Data Entry, set:

    • Collection Date = 27-SEP-2018

    • White Blood Cell = 18.8, Check (enable) Abnormal.

    • Red Blood Cell = 4.7, Check (enable) Normal

    • Hemoglobin = 18.5, Check (enable) Normal

    • Mean Cell Hemoglobin Conc = 40.2, Check (enable) Normal

    Click Final to save the data record.

  3. Select File > Exit to close DFexplore.

15.7. End Module 15.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click End to confirm successful completion of Module 15.

Chapter 16. Module 16: DFweb Data Entry

16.1. Introduction

[Warning]Warning

Optional Module.  The DFweb Data Entry module requires the DFWS feature (web services API). If your DFdiscover server is not licensed for this feature, do not complete this module.

DFweb is compatible with all web browsers that support the HTML5 standard, including the following web browsers:

  • Chrome

  • Safari

  • Edge

  • Firefox on Windows 10

16.2. Tests & Requirements

  1. Modify valid1 user permissions for DFweb entry.

  2. Verify DFweb version information, logging into DFweb and DFweb site certificate.

  3. Copying URL and changing user passwords.

  4. Creating a new subject, entering subject data.

  5. Adding, modifying and resolving queries.

  6. Adding, reviewing and downloading subject documents.

Estimate of Time Required: 15 Minutes

16.3. Begin Module 16.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 16 followed by Begin to begin this module.

[Note]Note

Save the Lab Report PDF files received via email to your local computer. This file is required to complete Section 16.9, “Adding, reviewing and downloading subject documents.”. Refer to Section 1.7, “Create a DFdiscover account for valid1.” as a valid email address is required for valid1 to receive the module specific PDF files.

16.4. Modify valid1 user permissions for DFweb entry.

  1. As user datafax open the login dialog for DFadmin as described in (Section 1.5, “Define Acceptance Test Study to the DFdiscover server.”). Enter the login name and password for user datafax and select Login. Click Login to login.

  2. In DFadmin, click Users tab. Choose the entry for valid1 from the list of users.

  3. Select Permissions tab, modify the existing Sites permissions by replacing Sites 'ALL' with '99'.

  4. Select File > Save or click Save to apply and save the modifications to the role. Select File > Exit to exit DFadmin.

16.5. Verify DFweb version information, logging into DFweb and DFweb site certificate.

[Note]Note

All remaining tests performed in this module have been completed using Google Chrome. Results and/or test steps may vary.

  1. Open a web browser and navigate to https://dfweb.dfdiscover.com/login, verify the version information: DFweb Version 5.2.0 is displayed.

  2. In the DFweb login dialog, enter the DFdiscover Server name that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. From the list of available studies, click 254 Acceptance Test Study to open its database.

    [Note]Note

    If valid1 only has access only to DFATK you will be taken directly to Site 99 Subjects view.

  4. Click from the web browser address bar. Select Certificate. The website trust certificate is displayed for the current DFweb address, click OK to close window.

16.6. Copying URL and changing user passwords.

  1. From the Subjects list, click Subject 99002 to open the 0: Screening Visits 1:Form 1 page.

  2. Copy the DFweb URL by clicking > Copy URL.

  3. Open a new browser tab, paste the copied URL into the new browser tab, click Enter. The pasted URL in the new tab re-directs you to the DFweb login page. Login again using valid1 credentials, upon logging in you are taken to the same subject data record as the previous web browser tab. Close the web browser tab.

    [Warning]Warning

    If you open a different browser program, you will be redirected to DFweb login page.

  4. From the breadcrumb bar, click Site 99. Click > Change password to view the Change Password window. Click Cancel to close.

16.7. Creating a new subject, entering subject data.

  1. From the Subjects list, click Subject 99010 to open the 0: Screening Visits 1:Form 1 page.

  2. Click Patient Initials enter ARX, Set:

    • Age (years) = 49

    • Sex = male

    • Race = caucasian

    • Screen 1 Date = Click icon, select 11-Nov-2018

    Click .

  3. Select 1:Baseline > 21:Lab Results page. Click Patient Initials field.

    [Note]Note

    The SetInit edit check executes upon entry to the field. If the initials are available on the 1 : Form 1 (previously entered), they are brought forward and populate the Patient Initials field.

  4. Set the remaining fields within the 21: Lab Results form as follows:

    • Collection Date = 13-NOV-2018

    • White Blood Cell = 15.3, Check (enable) NORMAL

    • Red Blood Cell = 04.3, Check (enable) NORMAL

    • Hemoglobin = 14.2, Check (enable) NORMAL

    • Mean Cell Hemoglobin Conc = 46.5, Check (enable) ABNORMAL

    Click .

16.8. Adding, modifying and resolving queries.

  1. From the breadcrumb bar, click Site 99 > Subject 99008 > 0:Screening Visits > 1:Blood Pressure Screening Visits. Change 6. Systolic and diastolic BP criteria from 'Yes' to 'No', Click then , select Resolved from the Status drop-down list. Click Apply, Close and to save the data record changes.

  2. Click 1:Baseline, from 2:Form 2 becomes the active form. Correct Date of Birth (dd/mm/yy) to '14/01/68'.

  3. Click then , select Resolved from the Status drop-down list. Click Apply, then Close to save the data record changes. Click .

  4. Click 21:Lab Results next to Mean Cell Hemoglobin Conc ABNORMAL/NORMAL field click . Enter Lab value confirmed as out of range. in the Reason field. Click Apply, .

16.9. Adding, reviewing and downloading subject documents.

  1. With subject 99008 21:Lab Results still the current record. Click > Manage documents to open the Manage documents window.

  2. Click Choose Files, select the previously saved labresults99008_module16.pdf (Refer to Step 2). Click Open > Upload to upload the document to DFdiscover.

  3. Click to view the newly uploaded document.

  4. The document can be zoomed in/out by using the navigation buttons within the document window.

  5. Click Close to close the Manage Documents window. Notice the icon has now changed to indicating the data record now has associated documents uploaded to DFdiscover.

  6. Click > Logout to exit DFweb.

16.10. End Module 16.

  • Return to the DFATK application. Click End to confirm successful completion of Module 16.

Chapter 17. Module 17: DFcollect Mobile Data Collection

17.1. Introduction

[Warning]Warning

Optional Module.  The DFweb Data Entry module requires the DFWS feature (web services API). If your DFdiscover server is not licensed for this feature, do not complete this module.

DFcollect is compatible with the following mobile device operating systems:

  • iOS®

  • Android

17.2. Tests & Requirements

  1. Modify valid1 user permissions for DFcollect entry.

  2. Installation, App preferences and initial DFcollect login.

  3. Online data record creation.

  4. Download subject data for offline use.

  5. Create data records in offline mode, query resolution and adding reasons for data values.

  6. Sync data collected offline to your DFdiscover server.

  7. Clearing DFcollect cache.

  8. Adding, reviewing and downloading subject documents.

  9. Confirming data sent to the server using DFexplore.

Estimate of Time Required: 20 Minutes

17.3. Begin Module 17.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 17 followed by Begin to begin this module.

17.4. Modify valid1 user permissions for DFcollect entry.

[Note]Note

If Chapter 16, Module 16: DFweb Data Entry was the last DFATK module completed proceed to Section 17.5, “Installation, App preferences and initial DFcollect login.” as the permissions for valid1 have previously been modified.

  1. As user datafax open the login dialog for DFadmin as described in (Section 1.5, “Define Acceptance Test Study to the DFdiscover server.”). Enter the login name and password for user datafax and select Login. Click Login to login.

  2. In DFadmin, click Users tab. Choose the entry for valid1 from the list of users.

  3. Select Permissions tab, confirm/modify the existing Sites permissions by replacing Sites 'ALL' with '99'.

  4. Select File > Save or click Save to apply and save the modifications to the role. Select File > Exit to exit DFadmin.

17.5. Installation, App preferences and initial DFcollect login.

  1. Download and install DFcollect from either Google Play or Apple® App Store® to your mobile device or tablet.

  2. Open DFcollect.

  3. Click > Preferences. Set:

    System Setting

    • API Server = your API servername

    • Offline Only = Disabled (greyed out)

    Click Close to apply settings.

  4. Click > About DFcollect to display version information. Click Close to return to the DFcollect login screen.

  5. In the DFcollect login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  6. From the list of available studies, click the 254 Acceptance Test Study to open its database.

    [Note]Note

    If valid1 only has access to DFATK you will be taken directly to the study sites view.

  7. Click 99: Hospital #99 to display a list of available subjects.

  8. Click > Study Help to view any study related help messages. Click OK to close the Study Help window.

  9. Click to search for a subject ID number, enter 99010 for the subject ID number. Click , subject 99010 : (Final) becomes the focus.

17.6. Online data record creation.

  1. Click subject 99010 : (Final) to view the list of study visits.

  2. Click 1: Baseline > 2: Form 2, Plate Form 2 becomes the active page.

  3. Click Patient Initials the initials automatically occupy this field as a result of the edit check SetInit described in Module 5: Image Data Entry, Set:

    • Entry Date = Click , select 14/11/18.

    • Medication Code # = 2524

    • Date of Birth = Click , select 11/05/69.

    Click .

  4. Click > > 99009 : (Incomplete) > 21: 1 Month Follow-up > 5: Form 5, 1 Month.

  5. Click Patient Initials the initials automatically occupy this field as a result of the edit check SetInit described in Module 5: Image Data Entry, Set:

    • Visit Date = Click , select 14/11/18.

    Click .

17.7. Download subject data for offline use.

  1. Click > Storage & Syncing.

  2. Click to show sites 99: Hospital #99 subject listing.

  3. Check (enable) subjects 99008: 0 visits, 99009: 0 visits and 99010: 0 visits.

  4. Click icon to download the subjects. Click OK to dismiss the Download Progress: Documents window. Upon successful download there will be an icon showing the date and time the download was performed.

  5. Click > Logout to logout of DFcollect.

17.8. Create data records in offline mode, query resolution and adding reasons for data values.

  1. Click > Preferences > Offline Only toggle button to enable Offline Only mode (becomes green). Click Close.

  2. In the DFcollect login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Click 99: Hospital #99 > 99009 : (incomplete) > 21: 1 Month Follow-up > 5: Monthly Follow-up Form. Set:

    • Blood Pressure: Reading 1: systolic = 142, diastolic = 097

    • Blood Pressure: Reading 2: systolic = 134, diastolic = 091

    • Blood Pressure: Arm = Right

    • Weight (lbs) = Click , select Missing Value from the Code drop-down list. Click Apply. Click Cancel in the resulting Add Query dialog.

    Click .

  4. Click > 21: Lab Results.

  5. Click Patient Initials the initials automatically occupy this field as a result of the edit check SetInit described in Module 5: Image Data Entry, Set:

    • Collection Date = Click , select 11-NOV-2018.

    • White Blood Cell = 07.8, check (enable) NORMAL

    • Red Blood Cell = 02.9 check (enable) NORMAL

    • Hemoglobin = 06.5, check (enable) ABNORMAL

    • Mean Cell Hemoglobin Conc = 14.1, check (enable) NORMAL

    Click .

  6. Click > 1: Baseline > 2: Patient Entry Form.

  7. Click next to the Pulse field. In the Reason field specify Value of 95 for pulse is confirmed.. Click Apply > .

  8. Click > > 99008 : (Final) > 1: Baseline > 2: Patient Entry Form. in the Date of First Study Follow-up field click , select 14/11/18.

  9. Click in the Reason field specify Subject has to reschedule due to conflict. Click Apply > .

  10. Click > > 99009 : (Incomplete) > 0: Screening Visits > 1: Blood Pressure Screening Visits.

  11. Correct Age (years) from 44 to 68. Click > , select Resolved from the Status drop-down list. Click Apply > Close.

  12. Click Race select african american, the query box changes from outstanding to resolved. Click .

  13. Click > > 99010 : (Incomplete) > 1: Baseline > 2: Patient Entry Form. Set:

    • Weight (lbs) = 267, click OK in the resulting dialog.

    • Height (in) = 072.8

    • Pulse = click , select Missing Value from the Code drop-down list.

    • Smoking Status = Never smoked

    • Date of First Study Follow-up = Click , select 05/12/18.

    Click .

    [Note]Note

    The Weight (kgs) and Height (cm) fields become auto-populated as a result of edit checks.

  14. Click > Logout, to logout of DFcollect.

17.9. Sync data collected offline to your DFdiscover server.

  1. Click > Preferences > Offline Only toggle button to disable the Offline Only mode (becomes greyed out). Click Close.

  2. In the DFcollect login dialog, enter the name for DFdiscover Server that has been provided by your administrator. Enter valid1 in the Username field and the previously assigned password in the Password field. Click Login to login.

  3. Upon logging into DFcollect, the icon is displayed next 99: Hospital #99 study site indicating there are cached changes in the DFcollect application that have not been saved to the DFdiscover database.

  4. Click > Storage & Syncing.

  5. Click to expand list of subjects. Check (enable) subjects 99008: 2 Visits, 99009: 3 visits and 99010: 2 visits.

  6. Click to upload the newly entered subject data. When the upload is completed, click the OK to dismiss the Upload Progresswidow. The icon is removed, the icon showing the date and time of successful upload is updated.

17.10. Clearing DFcollect cache.

  1. Check (enable) subjects 99008: 2 visits , 99009:3 visits and 99010:2 visits.

  2. Click then Apply within the Delete Records from Storage dialog. The icon showing the date and time are removed.

17.11. Adding, reviewing and downloading subject documents.

  1. Click > > 99008 : (Final) > 1: Baseline > 21: Lab Results.

  2. Click to view the attached documents.

  3. Clicking will allow you to upload a document from your mobile device.

  4. Click > Logout.

17.12. Confirming data sent to the server using DFexplore.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore.

  2. Select Site 99: Hospital #99 > subject 99009 > 0: Screening Visits > 1: Blood Pressure Screening Visits. Verify and review the data uploaded is correct.

    • Age (years) = 68 with a resolved corrected query.

    • Race = 2 (african american) with a resolved corrected query.

  3. Select File > Exit to close DFexplore.

17.13. End Module 17.

  • Return to the DFATK application. Click End to confirm successful completion of Module 17.

Chapter 18. Module 18: User-defined Property Tags

18.1. Tests & Requirements

  1. Defining User-defined property tags in DFsetup.

  2. Adding Global User-defined property values.

  3. Adding Plate, Module and Variable level User-defined property values

  4. Exporting User-defined property tags in DFsetup.

  5. Edit checks execution of User-defined property tags.

  6. Creating subject data lists and exporting data views.

  7. DFexplore Database Definition Report exporting.

Estimate of Time Required: 30 Minutes

18.2. Begin Module 18.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click Module 18 followed by Begin to begin this module.

  3. This module requires user valid1 to have exclusive access to the 254 Acceptance Test Study database, the Control Panel must be closed. Click Exit.

18.3. Defining User-defined property tags in DFsetup.

  1. Start DFsetup and choose 254 Acceptance Test Study as described in Section 1.7, “How to Start DFsetup.

  2. Choose Exclusive Access and click OK. Exclusive Access allows you to create and modify plates, styles and fields, and to define all setup configuration files.

  3. Select Study > User-defined Property Tags.

  4. Click the empty cell for USER1 DFSTUDY_ to make it the active field.

  5. Beginning with USER1 DFSTUDY_ column. Enter the User-defined property tags for DFSTUDY_ property tags as follows:

    • USER1 = TITLE

    • USER2 = SPONSOR

    • USER3 = PLANSUBJECTS

    • USER4 = TRIALPHASE

    • USER5 = TRIALTYPE

    • USER6 = LENGTH

    • USER7 = REGID

  6. Click USER1, DFPLATE_ column. Enter the User-defined property tags for DFPLATE_ property tags as follows:

    • USER1 = V1

    • USER2 = V2

  7. Click USER1 DFMODULE_ column. Enter the User-defined property tags for DFMODULE_ property tags as follows:

    • USER1 = XXTEST

    • USER2 = XXTERM

    • USER3 = XXTRT

    • USER4 = XXCAT

    • USER5 = XXSCAT

    • USER6 = XXFAST

  8. Click USER1 DFVAR_ column. Enter the User-defined property tags for DFVAR_ property tags as follows:

    • USER1 = EC_PLT_ENTER

    • USER2 = EC_FLD_ENTER

    • USER3 = EC_PLT_EXIT

    • USER4 = EC_FLD_EXIT

  9. Click OK to apply the newly defined properties.

18.4. Adding Global User-defined property values.

  1. Select Study > Global Settings. Click User-defined tab.

  2. In the User-defined tab set the following:

    • TITLE = DFdiscover 2019 Acceptance Test Study

    • SPONSOR = Pharma 123 Inc.

    • PLANSUBJECTS = 100

    • TRIALPHASE = PHASE III TRIAL

    • TRIALTYPE = TREATMENT

    • LENGTH = 4 MONTHS

    • REGID = NCT00000001

    Click OK.

18.5. Adding Plate, Module and Variable level User-defined property values

  1. Click 1 - Blood Pressure Screening Visits to make it the active page. Within the Plate Properties window click User-defined tab.

  2. Enter the Property Value tags as follows:

    • V1 = 1 October 2014

    • V2 = 11 November 2014 - Corrected error in Eligibility Criteria item 6.

    Click Apply.

  3. Select View > Plates.

  4. Within row 2 Patient Entry Form navigate to the V1 column. Enter 1 October 2014. In the V2 column enter 11 November 2014 - Updated randomization instructions.. Click Apply, Done.

  5. From the Plates-Modules-Fields window double-click 2 - Patient Entry Form. Click Keys [1] to make the module active.

  6. In the Module Properties window specify PTKEYS for the XXTEST Property Value. Click Apply.

  7. Double-click Randomization [1]. In the Module Properties window specify RANDCODE for the XXTEST Property Value. Click Apply.

  8. Select Medication Code # field. Click User-defined from the Field Properties window.

  9. Enter [MissingQC] Response is required. in the EC_FLD_EXIT Property Value.

  10. Click Edit checks tab within the Field Properties window.

  11. Enter MissingQC, sdv next to Field Exit, click Apply.

  12. Click Weight (lbs) field, then User-defined. Enter [WeightEquiv] Weight conversion. in the EC_FLD_EXIT Property Value. Click Apply.

  13. Select File > Save.

18.6. Exporting User-defined property tags in DFsetup.

  1. Select File > Export Setup >Excel.

  2. Click Field Properties ....

  3. In the resulting dialog, click Select none.

  4. Select Name, Alias, Description, EC_PLT_ENTER, EC_FLD_ENTER, EC_PLT_EXIT and EC_FLD_EXIT. Click OK.

  5. Specify module18_setup.xlsx as the Output File name, enable (check) Open output file after export.. Click Export.

  6. In the exported Excel file open the Global Settings tab to view the newly defined Global Property tags.

  7. Click 2 - Patient entry form to view the newly defined Plate Property tags. Return to DFsetup.

  8. Select File > Exit to close DFsetup.

18.7. Edit checks execution of User-defined property tags.

  1. Start DFexplore and choose 254 Acceptance Test Study as described in Section 1.6, “How to start DFexplore. Upon logging in a dfmessage edit check dialog is displayed containing the DFsetup-Global Settings User-defined property tags defined in Section 18.3, “Defining User-defined property tags in DFsetup.”.

  2. Select Select > Change Mode & Level. Set:

    • Mode = Validate

    • Save level = 3 - Level 3

    • Check (enable) Enable edit checks.

    Click OK.

  3. Double-click Site 99 - Hospital #99 > 99010 > 1 : Baseline > 2 : Form 2.

  4. Click anywhere on the page background to make the fields active. Press Tab to advance to the Medication Code # field.

  5. Press Tab to exit the field and execute the sdv edit check.

  6. Click OK to add the edit check containing the User-Defined Property Value's added in Section 18.3, “Defining User-defined property tags in DFsetup.”.

  7. Press Tab to advance through the remainder of the fields on the Patient Entry Form page. Verify that the Save information bar at the bottom of the screen indicates that the saved page will be assigned a record level of 3. Click Incomplete.

18.8. Creating subject data lists and exporting data views.

  1. Select View > List.

  2. Click 002 - Patient Entry Form.

  3. Select Select > Field Selection to show the listing of all data fields and their metadata properties defined for the plate. In the Data Fields window, click next to fields 7:SUBJID , 10:EXREFID , 12:WTKG , 13:WTLB.

    [Note]Note

    Alternatively fields can also be added by dragging-and-dropping the desired fields from the Data Fields or Metadata Fields windows to the Display Fields window.

  4. In the Metadata Fields window, click next to field EC_FLD_EXIT to add the field to the Display Fields window. From the drop-down select 10:EXREFID, click and drag the field to be below the 10:EXREFID - Medication Code # field.

  5. Return to the Metadata Fields window, click next to field EC_FLD_EXIT to add the field to the Display Fields window.. From the drop-down select 13:WTLB.

  6. Click Done to apply the field selection criteria and close the dialog.

  7. Select File > Export Data to save the data to a local file. In the dialog, set:

    • Format = Excel

    • Check (enable) Include header as the first record in output file.

  8. Click ... next to Output File. Choose a directory in the file selection dialog, enter module18_data.xlsx as the filename, and click Save. Click Save to create/write the file and close the dialog.

18.9. DFexplore Database Definition Report exporting.

  1. Select View > Reports.

  2. Double-click DFdiscover Reports > Study Setup > Database Definition.

  3. Click Run.

  4. In the report window click OPTIONS to expand the report options. Select Global Settings from View. Click OPTIONS to collapse the window.

  5. Select File > Save Output as > Excel.

  6. Click ... next to Output File. Choose a directory in the file selection dialog, enter module18_definitions.xlsx as the filename and click Save. Check (enable) Open output file after export and click Save.

18.10. End Module 18.

  1. Start DFATK as described in Module 1 (Installation & Initialization).

  2. Click End to confirm successful completion of Module 18.

Appendix A. Copyrights - Acknowledgments

A.1. External Software Copyrights

DFdiscover software uses several third-party software components as part of its server side and/or client tools.

The copyright information for each is provided below. If you would like to receive source codes of these third-party components, please send us your request at .

A.1.1. DCMTK software package

Copyright Copyright © 1994-2011, OFFIS e.V. All rights reserved.

This software and supporting documentation were developed by

OFFIS e.V.
      R&D Division Health
      Eschereg 2
      26121 OldenburgGermany

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

  • Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.

  • Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

  • Neither the name of OFFIS nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission.

THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

A.1.2. Jansson License

Copyright Copyright © 2009-2014 Petri Lehtinen <petri&digip.org>

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the Software), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

A.1.3. Mimencode

Copyright Copyright © 1991 Bell Communications Research, Inc. (Bellcore)

Permission to use, copy, modify, and distribute this material for any purpose and without fee is hereby granted, provided that the above copyright notice and this permission notice appear in all copies, and that the name of Bellcore not be used in advertising or publicity pertaining to this material without the specific, prior written permission of an authorized representative of Bellcore. BELLCORE MAKES NO REPRESENTATIONS ABOUT THE ACCURACY OR SUITABILITY OF THIS MATERIAL FOR ANY PURPOSE. IT IS PROVIDED AS IS, WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES.

A.1.4. RSA Data Security, Inc., MD5 message-digest algorithm

Copyright Copyright © 1991-2, RSA Data Security, Inc. Created 1991. All rights reserved. License to copy and use this software is granted provided that it is identified as the RSA Data Security, Inc. MD5 Message-Digest Algorithm in all material mentioning or referencing this software or this function. License is also granted to make and use derivative works provided that such works are identified as derived from the RSA Data Security, Inc. MD5 Message-Digest Algorithm in all material mentioning or referencing the derived work. RSA Data Security, Inc. makes no representations concerning either the merchantability of this software or the suitability of this software for any particular purpose. It is provided as is without express or implied warranty of any kind. These notices must be retained in any copies of any part of this documentation and/or software.

A.1.5. mpack/munpack

Copyright © Copyright 1993,1994 by Carnegie Mellon University All Rights Reserved.

Permission to use, copy, modify, distribute, and sell this software and its documentation for any purpose is hereby granted without fee, provided that the above copyright notice appear in all copies and that both that copyright notice and this permission notice appear in supporting documentation, and that the name of Carnegie Mellon University not be used in advertising or publicity pertaining to distribution of the software without specific, written prior permission. Carnegie Mellon University makes no representations about the suitability of this software for any purpose. It is provided as is without express or implied warranty.

CARNEGIE MELLON UNIVERSITY DISCLAIMS ALL WARRANTIES WITH REGARD TO THIS SOFTWARE, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS, IN NO EVENT SHALL CARNEGIE MELLON UNIVERSITY BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTIOUS ACTION, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.

A.1.6. TIFF

Copyright Copyright © 1988-1997 Sam Leffler Copyright Copyright © 1991-1997 Silicon Graphics, Inc.

Permission to use, copy, modify, distribute, and sell this software and its documentation for any purpose is hereby granted without fee, provided that (i) the above copyright notices and this permission notice appear in all copies of the software and related documentation, and (ii) the names of Sam Leffler and Silicon Graphics may not be used in any advertising or publicity relating to the software without the specific, prior written permission of Sam Leffler and Silicon Graphics.

THE SOFTWARE IS PROVIDED AS-IS AND WITHOUT WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL SAM LEFFLER OR SILICON GRAPHICS BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER OR NOT ADVISED OF THE POSSIBILITY OF DAMAGE, AND ON ANY THEORY OF LIABILITY, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.

A.1.7. PostgreSQL

Portions Copyright © 1996-2019, PostgreSQL Global Development Group Portions Copyright © 1994, The Regents of the University of California

Permission to use, copy, modify, and distribute this software and its documentation for any purpose, without fee, and without a written agreement is hereby granted, provided that the above copyright notice and this paragraph and the following two paragraphs appear in all copies.

IN NO EVENT SHALL THE UNIVERSITY OF CALIFORNIA BE LIABLE TO ANY PARTY FOR DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS, ARISING OUT OF THE USE OF THIS SOFTWARE AND ITS DOCUMENTATION, EVEN IF THE UNIVERSITY OF CALIFORNIA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

THE UNIVERSITY OF CALIFORNIA SPECIFICALLY DISCLAIMS ANY WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THE SOFTWARE PROVIDED HEREUNDER IS ON AN "AS IS" BASIS, AND THE UNIVERSITY OF CALIFORNIA HAS NO OBLIGATIONS TO PROVIDE MAINTENANCE, SUPPORT, UPDATES, ENHANCEMENTS, OR MODIFICATIONS.

A.1.8. OpenSSL License

Copyright Copyright © 1998-2019 The OpenSSL Project. All rights reserved.

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

  1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.

  2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

  3. All advertising materials mentioning features or use of this software must display the following acknowledgment: This product includes software developed by the OpenSSL Project for use in .the OpenSSL Toolkit. (http://www.openssl.org/)

  4. The names OpenSSL Toolkit and "OpenSSL Project" must not be used to endorse or promote products derived from this software without prior written permission. For written permission, please contact openssl-core@openssl.org.

  5. Products derived from this software may not be called OpenSSL nor may OpenSSL appear in their names without prior written permission of the OpenSSL Project.

  6. Redistributions of any form whatsoever must retain the following acknowledgment: This product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit. (http://www.openssl.org)

THIS SOFTWARE IS PROVIDED BY THE OpenSSL PROJECT AS IS AND ANY EXPRESSED OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE OpenSSL PROJECT OR ITS CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

This product includes cryptographic software written by Eric Young (). This product includes software written by Tim Hudson ().

A.1.9. Original SSLeay License

Copyright Copyright © 1995-1998 Eric Young () All rights reserved.

This package is an SSL implementation written by Eric Young (). The implementation was written so as to conform with Netscapes SSL.

This library is free for commercial and non-commercial use as long as the following conditions are aheared to. The following conditions apply to all code found in this distribution, be it the RC4, RSA, lhash, DES, etc., code; not just the SSL code. The SSL documentation included with this distribution is covered by the same copyright terms except that the holder is Tim Hudson ().

Copyright remains Eric Young's, and as such any Copyright notices in the code are not to be removed. If this package is used in a product, Eric Young should be given attribution as the author of the parts of the library used. This can be in the form of a textual message at program startup or in documentation (online or textual) provided with the package.

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

  1. Redistributions of source code must retain the copyright notice, this list of conditions and the following disclaimer.

  2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

  3. All advertising materials mentioning features or use of this software must display the following acknowledgement: This product includes cryptographic software written by Eric Young () The word cryptographic can be left out if the rouines from the library being used are not cryptographic related :-).

  4. If you include any Windows specific code (or a derivative thereof) from the apps directory (application code) you must include an acknowledgement: This product includes software written by Tim Hudson ()

THIS SOFTWARE IS PROVIDED BY ERIC YOUNG AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

The licence and distribution terms for any publically available version or derivative of this code cannot be changed. i.e. this code cannot simply be copied and put under another distribution licence [including the GNU Public Licence.]

A.1.10. gawk

GNU GENERAL PUBLIC LICENSE Version 2, June 1991

http://www.gnu.org/licenses/gpl-2.0.html

Copyright Copyright © 1989, 1991 Free Software Foundation, Inc.


        51 Franklin Street, Fifth Floor
        BostonMA  02110-1301USA

Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed.

The licenses for most software are designed to take away your freedom to share and change it. By contrast, the GNU General Public License is intended to guarantee your freedom to share and change free software--to make sure the software is free for all its users. This General Public License applies to most of the Free Software Foundation's software and to any other program whose authors commit to using it. (Some other Free Software Foundation software is covered by the GNU Lesser General Public License instead.) You can apply it to your programs, too.

When we speak of free software, we are referring to freedom, not price. Our General Public Licenses are designed to make sure that you have the freedom to distribute copies of free software (and charge for this service if you wish), that you receive source code or can get it if you want it, that you can change the software or use pieces of it in new free programs; and that you know you can do these things.

To protect your rights, we need to make restrictions that forbid anyone to deny you these rights or to ask you to surrender the rights. These restrictions translate to certain responsibilities for you if you distribute copies of the software, or if you modify it.

For example, if you distribute copies of such a program, whether gratis or for a fee, you must give the recipients all the rights that you have. You must make sure that they, too, receive or can get the source code. And you must show them these terms so they know their rights.

We protect your rights with two steps: (1) copyright the software, and (2) offer you this license which gives you legal permission to copy, distribute and/or modify the software.

Also, for each author's protection and ours, we want to make certain that everyone understands that there is no warranty for this free software. If the software is modified by someone else and passed on, we want its recipients to know that what they have is not the original, so that any problems introduced by others will not reflect on the original authors' reputations.

Finally, any free program is threatened constantly by software patents. We wish to avoid the danger that redistributors of a free program will individually obtain patent licenses, in effect making the program proprietary. To prevent this, we have made it clear that any patent must be licensed for everyone's free use or not licensed at all.

The precise terms and conditions for copying, distribution and modification follow.

TERMS AND CONDITIONS FOR COPYING, DISTRIBUTION AND MODIFICATION

  1. This License applies to any program or other work which contains a notice placed by the copyright holder saying it may be distributed under the terms of this General Public License. The Program, below, refers to any such program or work, and a work based on the Program means either the Program or any derivative work under copyright law: that is to say, a work containing the Program or a portion of it, either verbatim or with modifications and/or translated into another language. (Hereinafter, translation is included without limitation in the term modification.) Each licensee is addressed as you.

    Activities other than copying, distribution and modification are not covered by this License; they are outside its scope. The act of running the Program is not restricted, and the output from the Program is covered only if its contents constitute a work based on the Program (independent of having been made by running the Program). Whether that is true depends on what the Program does.

  2. You may copy and distribute verbatim copies of the Program's source code as you receive it, in any medium, provided that you conspicuously and appropriately publish on each copy an appropriate copyright notice and disclaimer of warranty; keep intact all the notices that refer to this License and to the absence of any warranty; and give any other recipients of the Program a copy of this License along with the Program.

    You may charge a fee for the physical act of transferring a copy, and you may at your option offer warranty protection in exchange for a fee.

  3. You may modify your copy or copies of the Program or any portion of it, thus forming a work based on the Program, and copy and distribute such modifications or work under the terms of Section 1 above, provided that you also meet all of these conditions:

    1. You must cause the modified files to carry prominent notices stating that you changed the files and the date of any change.

    2. You must cause any work that you distribute or publish, that in whole or in part contains or is derived from the Program or any part thereof, to be licensed as a whole at no charge to all third parties under the terms of this License.

    3. If the modified program normally reads commands interactively when run, you must cause it, when started running for such interactive use in the most ordinary way, to print or display an announcement including an appropriate copyright notice and a notice that there is no warranty (or else, saying that you provide a warranty) and that users may redistribute the program under these conditions, and telling the user how to view a copy of this License. (Exception: if the Program itself is interactive but does not normally print such an announcement, your work based on the Program is not required to print an announcement.) These requirements apply to the modified work as a whole. If identifiable sections of that work are not derived from the Program, and can be reasonably considered independent and separate works in themselves, then this License, and its terms, do not apply to those sections when you distribute them as separate works. But when you distribute the same sections as part of a whole which is a work based on the Program, the distribution of the whole must be on the terms of this License, whose permissions for other licensees extend to the entire whole, and thus to each and every part regardless of who wrote it.

      Thus, it is not the intent of this section to claim rights or contest your rights to work written entirely by you; rather, the intent is to exercise the right to control the distribution of derivative or collective works based on the Program.

      In addition, mere aggregation of another work not based on the Program with the Program (or with a work based on the Program) on a volume of a storage or distribution medium does not bring the other work under the scope of this License.

  4. You may copy and distribute the Program (or a work based on it, under Section 2) in object code or executable form under the terms of Sections 1 and 2 above provided that you also do one of the following:

    1. Accompany it with the complete corresponding machine-readable source code, which must be distributed under the terms of Sections 1 and 2 above on a medium customarily used for software interchange; or,

    2. Accompany it with a written offer, valid for at least three years, to give any third party, for a charge no more than your cost of physically performing source distribution, a complete machine-readable copy of the corresponding source code, to be distributed under the terms of Sections 1 and 2 above on a medium customarily used for software interchange; or,

    3. Accompany it with the information you received as to the offer to distribute corresponding source code. (This alternative is allowed only for noncommercial distribution and only if you received the program in object code or executable form with such an offer, in accord with Subsection b above.) The source code for a work means the preferred form of the work for making modifications to it. For an executable work, complete source code means all the source code for all modules it contains, plus any associated interface definition files, plus the scripts used to control compilation and installation of the executable. However, as a special exception, the source code distributed need not include anything that is normally distributed (in either source or binary form) with the major components (compiler, kernel, and so on) of the operating system on which the executable runs, unless that component itself accompanies the executable.

      If distribution of executable or object code is made by offering access to copy from a designated place, then offering equivalent access to copy the source code from the same place counts as distribution of the source code, even though third parties are not compelled to copy the source along with the object code.

  5. You may not copy, modify, sublicense, or distribute the Program except as expressly provided under this License. Any attempt otherwise to copy, modify, sublicense or distribute the Program is void, and will automatically terminate your rights under this License. However, parties who have received copies, or rights, from you under this License will not have their licenses terminated so long as such parties remain in full compliance.

  6. You are not required to accept this License, since you have not signed it. However, nothing else grants you permission to modify or distribute the Program or its derivative works. These actions are prohibited by law if you do not accept this License. Therefore, by modifying or distributing the Program (or any work based on the Program), you indicate your acceptance of this License to do so, and all its terms and conditions for copying, distributing or modifying the Program or works based on it.

  7. Each time you redistribute the Program (or any work based on the Program), the recipient automatically receives a license from the original licensor to copy, distribute or modify the Program subject to these terms and conditions. You may not impose any further restrictions on the recipients' exercise of the rights granted herein. You are not responsible for enforcing compliance by third parties to this License.

  8. If, as a consequence of a court judgment or allegation of patent infringement or for any other reason (not limited to patent issues), conditions are imposed on you (whether by court order, agreement or otherwise) that contradict the conditions of this License, they do not excuse you from the conditions of this License. If you cannot distribute so as to satisfy simultaneously your obligations under this License and any other pertinent obligations, then as a consequence you may not distribute the Program at all. For example, if a patent license would not permit royalty-free redistribution of the Program by all those who receive copies directly or indirectly through you, then the only way you could satisfy both it and this License would be to refrain entirely from distribution of the Program.

    If any portion of this section is held invalid or unenforceable under any particular circumstance, the balance of the section is intended to apply and the section as a whole is intended to apply in other circumstances.

    It is not the purpose of this section to induce you to infringe any patents or other property right claims or to contest validity of any such claims; this section has the sole purpose of protecting the integrity of the free software distribution system, which is implemented by public license practices. Many people have made generous contributions to the wide range of software distributed through that system in reliance on consistent application of that system; it is up to the author/donor to decide if he or she is willing to distribute software through any other system and a licensee cannot impose that choice.

    This section is intended to make thoroughly clear what is believed to be a consequence of the rest of this License.

  9. If the distribution and/or use of the Program is restricted in certain countries either by patents or by copyrighted interfaces, the original copyright holder who places the Program under this License may add an explicit geographical distribution limitation excluding those countries, so that distribution is permitted only in or among countries not thus excluded. In such case, this License incorporates the limitation as if written in the body of this License.

  10. The Free Software Foundation may publish revised and/or new versions of the General Public License from time to time. Such new versions will be similar in spirit to the present version, but may differ in detail to address new problems or concerns.

    Each version is given a distinguishing version number. If the Program specifies a version number of this License which applies to it and "any later version", you have the option of following the terms and conditions either of that version or of any later version published by the Free Software Foundation. If the Program does not specify a version number of this License, you may choose any version ever published by the Free Software Foundation.

  11. If you wish to incorporate parts of the Program into other free programs whose distribution conditions are different, write to the author to ask for permission. For software which is copyrighted by the Free Software Foundation, write to the Free Software Foundation; we sometimes make exceptions for this. Our decision will be guided by the two goals of preserving the free status of all derivatives of our free software and of promoting the sharing and reuse of software generally. NO WARRANTY

  12. BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE, THERE IS NO WARRANTY FOR THE PROGRAM, TO THE EXTENT PERMITTED BY APPLICABLE LAW. EXCEPT WHEN OTHERWISE STATED IN WRITING THE COPYRIGHT HOLDERS AND/OR OTHER PARTIES PROVIDE THE PROGRAM AS IS WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE PROGRAM IS WITH YOU. SHOULD THE PROGRAM PROVE DEFECTIVE, YOU ASSUME THE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION.

  13. IN NO EVENT UNLESS REQUIRED BY APPLICABLE LAW OR AGREED TO IN WRITING WILL ANY COPYRIGHT HOLDER, OR ANY OTHER PARTY WHO MAY MODIFY AND/OR REDISTRIBUTE THE PROGRAM AS PERMITTED ABOVE, BE LIABLE TO YOU FOR DAMAGES, INCLUDING ANY GENERAL, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE THE PROGRAM (INCLUDING BUT NOT LIMITED TO LOSS OF DATA OR DATA BEING RENDERED INACCURATE OR LOSSES SUSTAINED BY YOU OR THIRD PARTIES OR A FAILURE OF THE PROGRAM TO OPERATE WITH ANY OTHER PROGRAMS), EVEN IF SUCH HOLDER OR OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

A.1.11. Ghostscript

The files in the base, psi, lib, toolbin, examples, doc and man directories (folders) and any subdirectories (sub-folders) thereof are part of GPL Ghostscript.

The files in the Resource directory and any subdirectories thereof are also part of GPL Ghostscript, with the explicit exception of the files in the CMap subdirectory (except Identity-UTF16-H, which is part of GPL Ghostscript). The CMap files are copyright Adobe Systems Incorporated and covered by a separate, GPL compatible license.

The files under the jpegxr directory and any subdirectories thereof are distributed under a no cost, open source license granted by the ITU/ISO/IEC but it is not GPL compatible - see jpegxr/COPYRIGHT.txt for details.

GPL Ghostscript is free software; you can redistribute it and/or modify it under the terms the GNU General Public License as published by the Free Software Foundation, either version 3 of the License, or (at your option) any later version.

GPL Ghostscript is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY; without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. See the GNU General Public License for more details.

You should have received a copy of the GNU General Public License along with this program so you can know your rights and responsibilities. It should be in a file named doc/COPYING. If not, write to the


    Free Software Foundation, Inc., 59 Temple Place Suite 330BostonMA
    02111-1307USA.
    

GPL Ghostscript contains an implementation of techniques covered by US Patents 5,055,942 and 5,917,614, and corresponding international patents. These patents are licensed for use with GPL Ghostscript under the following grant:

Whereas, Raph Levien (hereinafter Inventor) has obtained patent protection for related technology (hereinafter Patented Technology), Inventor wishes to aid the the GNU free software project in achieving its goals, and Inventor also wishes to increase public awareness of Patented Technology, Inventor hereby grants a fully paid up, nonexclusive, royalty free license to practice the patents listed below (the Patents) if and only if practiced in conjunction with software distributed under the terms of any version of the GNU General Public License as published by the

Free Software Foundation, 59 Temple Place, Suite
        330
BostonMA 02111

Inventor reserves all other rights, including without limitation, licensing for software not distributed under the GNU General Public License.

5055942 Photographic image reproduction device using digital halftoning to para images allowing adjustable coarseness 5917614 Method and apparatus for error diffusion paraing of images with improved smoothness in highlight and shadow regions

A.1.12. MariaDB and FreeTDS

GNU LESSER GENERAL PUBLIC LICENSE Version 2.1, February 1999 http://www.gnu.org/licenses/lgpl-2.1.html

Copyright Copyright © 1991, 1999


    Free Software Foundation, Inc.
    51 Franklin Street, Fifth FloorBostonMA  02110-1301  USA

Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed.

[This is the first released version of the Lesser GPL. It also counts as the successor of the GNU Library Public License, version 2, hence the version number 2.1.]

Preamble The licenses for most software are designed to take away your freedom to share and change it. By contrast, the GNU General Public Licenses are intended to guarantee your freedom to share and change free software--to make sure the software is free for all its users.

This license, the Lesser General Public License, applies to some specially designated software packages--typically libraries--of the Free Software Foundation and other authors who decide to use it. You can use it too, but we suggest you first think carefully about whether this license or the ordinary General Public License is the better strategy to use in any particular case, based on the explanations below.

When we speak of free software, we are referring to freedom of use, not price. Our General Public Licenses are designed to make sure that you have the freedom to distribute copies of free software (and charge for this service if you wish); that you receive source code or can get it if you want it; that you can change the software and use pieces of it in new free programs; and that you are informed that you can do these things.

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A.1.13. QtAV

Copyright © Wang Bin Shanghai University->S3 Graphics->Deepin, Shanghai, China 2013-01-21

**QtAV is free software licensed under the term of LGPL v2.1. The player example is licensed under GPL v3. If you use QtAV or its constituent libraries, you must adhere to the terms of the license in question.**

Rather than repeating the text of the LGPL v2.1, the original text can be found in GNU LESSER GENERAL PUBLIC LICENSE, Version 2.1.

A.1.14. FFmpeg

Most files in FFmpeg are under the GNU Lesser General Public License version 2.1 or later (LGPL v2.1+). Read the file `COPYING.LGPLv2.1` for details. Some other files have MIT/X11/BSD-style licenses. In combination the LGPL v2.1+ applies to FFmpeg.

Rather than repeating the text of the LGPL v2.1, the original text can be found in GNU LESSER GENERAL PUBLIC LICENSE, Version 2.1.

A.1.15. c3.js

The MIT License (MIT) Copyright © 2013 Masayuki Tanaka

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

A.1.16. d3.js

Copyright 2010-2017 Mike Bostock All rights reserved.

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met: * Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer. * Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. * Neither the name of the author nor the names of contributors may be used to endorse or promote products derived from this software without specific prior written permission.

THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.