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 datafax.
1.7. Creating study roles and permissions.
1.8. Creating user accounts and assigning study permissions.
1.9. Enable high definition imaging.
1.10. Start the Acceptance Test Study Control Panel application.
2. Module 2. DFdiscover Client Applications
2.1. Tests & Requirements
2.2. Begin Module 2. DFdiscover Client Applications.
2.3. Send PDF images to DFexplore.
2.4. Verify the online 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. Verify the online setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.
2.8. End Module 2. DFdiscover Client Applications.
3. Module 3. Study Setup
3.1. Tests & Requirements
3.2. Begin Module 3. Study Setup.
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 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 defined 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. Study Setup.
4. Module 4. eCRF Creation for DFdiscover
4.1. Tests & Requirements
4.2. Introduction
4.3. Begin Module 4. eCRF Creation.
4.4. eCRF creation in DFsetup.
4.5. eCRF background color preferences.
4.6. Entering eCRF data.
4.7. End Module 4. eCRF Creation.
5. Module 5. User-defined Properties
5.1. Tests & Requirements
5.2. Begin Module 5. User-defined Properties.
5.3. Defining User-defined property tags in DFsetup.
5.4. Adding Global User-defined property values.
5.5. Adding Plate, Module and Variable level User-defined property values
5.6. Exporting User-defined property tags in DFsetup.
5.7. Edit checks execution of User-defined property tags.
5.8. Creating subject data lists and exporting data views.
5.9. DFexplore Database Definition Report exporting.
5.10. End Module 5. User-defined Properties.
6. Module 6. Subject Alias
6.1. Tests & Requirements
6.2. Begin Module 6. Subject Alias.
6.3. Importing and Modifying Subject Alias Map using DFsetup.
6.4. Creating Subjects using Subject Alias.
6.5. Subject Alias Tracking (Reports).
6.6. Exporting Subject Alias data.
6.7. End Module 6. Subject Alias.
7. Module 7. EDC Data Entry
7.1. Tests & Requirements
7.2. Begin Module 7. EDC Data Entry.
7.3. Login to DFexplore and inspect the list of sites, subjects and visits in the record list window.
7.4. Enter and save new data using EDC data entry for Subject 99007.
7.5. Add reasons to explain entered data values.
7.6. Enter and save Plate 3, Subject 99007 as a pending record.
7.7. Mark and save unavailable data as missed. Unmark available data as missed.
7.8. Retrieve and modify existing data using a predefined task and save modifications to the database.
7.9. Confirm audit trail information for entered and modified data.
7.10. End Module 7. EDC Data Entry.
8. Module 8. Image Data Entry
8.1. Tests & Requirements
8.2. Begin Module 8. Image Data Entry
8.3. Send PDF images to DFexplore.
8.4. Login to DFexplore and confirm the receipt of new pages in the Status View.
8.5. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.
8.6. Login to DFexplore and confirm receipt of the routed page in the Status View.
8.7. Retrieve new images in DFexplore Image View.
8.8. Enter Plate 1 (Form 1) for Subject 99002.
8.9. Enter Plate 2 (Form 2) for Subject 99002.
8.10. Enter Plate 3 (Form 3) for Subject 99002.
8.11. Enter Plate 4 (Form 4) for Subject 99002.
8.12. Compare the resolutions between Standard Definition (SD) and High Definition (HD).
8.13. Edit an existing query.
8.14. Delete an existing query.
8.15. Change data and record a reason for data change.
8.16. Batch validate all opened pages for Subject 99002 to level 2.
8.17. Confirm the status of entered pages in Status View.
8.18. End Module 8. Image Data Entry.
9. Module 9. User-defined Query Category Types
9.1. Tests & Requirements
9.2. Begin Module 9. User-defined Query Category Types.
9.3. Retrieve an existing data record in DFexplore.
9.4. Apply a user-defined Category query.
9.5. Add a reason for Data Value to explain entered data.
9.6. Edit an existing query.
9.7. Delete a user-defined Query Category that is used by an existing query.
9.8. Delete a user-defined Category query.
9.9. End Module 9. User-defined Query Category Types.
10. Module 10. Multiple Queries Per Field
10.1. Tests & Requirements
10.2. Begin Module 10. Multiple Queries Per Field.
10.3. Submit PDF images to DFdiscover.
10.4. Enable multiple queries per field in DFsetup.
10.5. Retrieve submitted CRF in DFexplore Image View.
10.6. Enter Plate 9 for Subject 99002.
10.7. Apply multiple queries to a field.
10.8. Select and edit an existing query in a field that has multiple queries.
10.9. Select and reply to an existing query in a field that has multiple queries.
10.10. Select and delete an existing query in a field that has multiple queries.
10.11. End Module 10. Multiple Queries Per Field
11. Module 11. Data Review
11.1. Tests & Requirements
11.2. Begin Module 11. Data Review.
11.3. Retrieve all data for Site 99 that exists at level 3.
11.4. Review and approve a pending reason for data value, and approve a selected query in a field that has multiple queries.
11.5. Review and move approved reasons for data values to a higher workflow level, and review queries in a field that has multiple queries.
11.6. Data review and add a query to inconsistent data.
11.7. Review and complete pending data for Subject 99007.
11.8. Confirm audit trail information for reviewed and modified data.
11.9. Run batch edit checks to verify data integrity.
11.10. Use a data expression to retrieve specific subject information.
11.11. Use cross-plate data criteria to retrieve specific subject information.
11.12. End Module 11. Data Review.
12. Module 12. External Query Reports
12.1. Tests & Requirements
12.2. Begin Module 12. External Query Reports.
12.3. Obtain database query metrics and details using Status and List Views to review all outstanding queries prior to query report creation.
12.4. Run database integrity check report DF_XXkeys to export all key fields and visit dates from required plates in the database.
12.5. Use Data View to check, and if necessary correct, illegal visit dates by retrieving the problems keys identified by DF_XXkeys.
12.6. Execute DF_QCupdate to update the query database and lock all records for query report generation.
12.7. Execute DF_QCreports to create a standard, 3-part external query report for a study site.
12.8. Confirm the status of external queries following query report creation.
12.9. Execute DF_QCstatus to verify that a new query report was created by listing all reports in the QC/NEW directory.
12.10. Execute DF_QCview to display the newly created query report.
12.11. Execute DF_QCprint to print the query report from the QC/NEW directory.
12.12. Comparing several examples from the printed query report against their corresponding queries in the study database.
12.13. Execute DF_QCfax to email the query report to a valid email account.
12.14. Verify the status of the queries in the sent report.
12.15. End Module 12. External Query Reports.
13. Module 13. Replying to EDC Queries, eSignatures
13.1. Tests & Requirements
13.2. Begin Module 13. Replying to EDC Queries, eSignatures.
13.3. Determine a count of outstanding/outstanding queries in Status View.
13.4. Review outstanding queries in Queries View.
13.5. Using EDC, locate and reply to outstanding clarification queries.
13.6. Add an Electronic Signature (eSign) to a set of completed subject records.
13.7. End Module 13. Replying to EDC Queries, eSignatures.
14. Module 14. Re-submitting Query Corrections
14.1. Tests & Requirements
14.2. Begin Module 14. Re-submitting Query Corrections.
14.3. Submit PDF images to DFdiscover.
14.4. Verify that all CRFs have arrived successfully in Image view.
14.5. Retrieve submitted CRFs using DFexplore Image View.
14.6. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.
14.7. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.
14.8. Enter Form 4, Subject 99004.
14.9. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.
14.10. Select and resolve a query in a field that has multiple queries.
14.11. Review and approve a pending query reply for Form 1 for Subject 99002.
14.12. Review, correct and approve a pending query reply for Form 1, Subject 99007.
14.13. Confirm query resolution by examining the database status.
14.14. End Module 14. Re-submitting Query Corrections.
15. Module 15. Data Export and DFsas
15.1. Tests & Requirements
15.2. Begin Module 15. Data Export and DFsas.
15.3. Export date values in calender format and save the exported data to a file on the local computer.
15.4. Export date values from the database and save the exported data to a file on the local computer.
15.5. Examining data values according to user-specified criteria.
15.6. Query the database for specific data values.
15.7. Create a DFsas job file according to user-specified criteria.
15.8. Create a SAS job file and data files using the DFsas job file criteria.
15.9. Compare the contents of SAS data files with the actual data in the database.
15.10. End Module 15. Data Export and DFsas.
16. Module 16. PDF File Creation
16.1. Tests & Requirements
16.2. Begin Module 16. PDF File Creation.
16.3. Retrieve existing data according to user-specified criteria.
16.4. Saving DFexplore data to a standard PDF document.
16.5. Viewing a standard PDF data file using a PDF viewer application.
16.6. Saving DFexplore data to an encrypted bookmarked PDF file.
16.7. Open and view an encrypted bookmarked PDF file using a PDF viewer application.
16.8. Create a complete subject package PDF file that includes data records, CRF images and audit trail.
16.9. Open and view a PDF subject package using a PDF viewer application.
16.10. End Module 16. PDF File Creation.
17. Module 17. DFweb Data Entry
17.1. Introduction
17.2. Tests & Requirements
17.3. Begin Module 17. DFweb Data Entry.
17.4. Verify DFweb version information, logging into DFweb and DFweb site certificate verification.
17.5. Copying URL and changing user passwords.
17.6. Creating a new subject, entering subject data.
17.7. Adding, modifying and resolving queries.
17.8. Adding, reviewing and downloading subject documents.
17.9. End Module 17. DFweb.
18. Module 18. DFcollect Mobile Data Collection
18.1. Introduction
18.2. Tests & Requirements
18.3. Begin Module 18. DFcollect Mobile Data Collection.
18.4. Installation, App preferences and initial DFcollect login.
18.5. Online data record creation.
18.6. Download subject data for offline use.
18.7. Create data records in offline mode, query resolution and adding reasons for data values.
18.8. Sync data collected offline to your DFdiscover server.
18.9. Clearing DFcollect cache.
18.10. Adding, reviewing and downloading subject documents.
18.11. Confirming data sent to the server using DFexplore.
18.12. End Module 18. DFcollect.