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. Verify the on-line user documentation. Open the Image Router and verify the appearance of the Welcome Fax.
- 2.4. Open the Acceptance Test Study and verify the standard DFexplore views.
- 2.5. Start DFsetup and verify version information.
- 2.6. Login and verify the on-line setup documentation. Open the Acceptance Test Study setup and verify the standard DFsetup views.
- 2.7. 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: Fax Data Entry
- 5.1. Tests & Requirements
- 5.2. Begin Module 5
- 5.3. Login to DFexplore and confirm the receipt of new pages in the Status View.
- 5.4. Login to the Image Router and route a misidentified page to the Acceptance Test Study new record queue.
- 5.5. Login to DFexplore and confirm receipt of the routed page in the Status View.
- 5.6. Retrieve new images in DFexplore Image View.
- 5.7. Enter Plate 1 (Form 1) for Subject 99002.
- 5.8. Enter Plate 2 (Form 2) for Subject 99002.
- 5.9. Enter Plate 3 (Form 3) for Subject 99002.
- 5.10. Enter Plate 4 (Form 4) for Subject 99002.
- 5.11. Compare the resolutions between Standard Definition (SD) version of an image and High Definition (HD) version of the same image.
- 5.12. Edit an existing query.
- 5.13. Delete an existing query.
- 5.14. Change data and record a reason for data change.
- 5.15. Batch validate all opened pages for Subject 99002 to level 2.
- 5.16. Confirm the status of entered pages in Status View.
- 5.17. 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. Enable multiple queries per field in DFsetup.
- 7.4. Retrieve submitted CRF in DFexplore Image View.
- 7.5. Enter Plate 9 for Subject 99002.
- 7.6. Apply multiple queries to a field.
- 7.7. Select and edit an existing query in a field that has multiple queries.
- 7.8. Select and reply to an existing query in a field that has multiple queries.
- 7.9. Select and delete an existing query in a field that has multiple queries.
- 7.10. 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: Refaxing CRFs and Correcting Queries
- 12.1. Tests & Requirements
- 12.2. Begin Module 12.
- 12.3. Submit corrected case report forms into the study database and verify that all CRFs have arrived successfully in the new record queue.
- 12.4. Retrieve submitted CRFs using DFexplore Image View.
- 12.5. Enter Form 2, Subject 99001, resolve outstanding queries, and save the corrected CRF to the database.
- 12.6. Enter Form 2, Subject 99002, resolve outstanding queries, and save the corrected CRF to the database.
- 12.7. Enter Form 4, Subject 99004.
- 12.8. Enter Form 2, Subject 99004, resolve outstanding queries, and save the corrected CRF to the database.
- 12.9. Select and resolve a query in a field that has multiple queries.
- 12.10. Review and approve a pending query reply for Form 1 for Subject 99002.
- 12.11. Review, correct and approve a pending query reply for Form 1, Subject 99007.
- 12.12. Confirm query resolution by examining the database status.
- 12.13. 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.