User Acceptance/Validating Studies
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      Study Validation and User Acceptance

      Documenting the Study Design and Study Validation

      Formal study validation is an important step for GCP and compliance. Please refer to the applicable governing regulations to best identify if these steps are necessary for your study and what other steps may need to be considered.

      It’s important to consider that TrialKit’s functions are all certified at a system level under a common use case and can be guaranteed by CDS to function appropriately.

      The idea behind study validation, as it's covered here, is to verify that a given function works the way it is being used for a given study in the way it requires. The validation process also helps catch some settings that may have been unintentionally missed or misunderstood during the study build.


      NOTE: It is important to follow your organization's Standard Operating Procedures (SOPs).  This Knowledge Base provides suggestions in documenting information to assist in completing user acceptance and study validation, but should not dictate your process.

      Start by exporting the items listed below.

      Summary of what will be validated from the documents above:

      • Form-level conditional actions

      • Field-level conditional actions

      • Form rules (properties)

      • Study role access

      • Form view/edit rights

      • Field Blinding

      • Visit Schedule date windows

      Steps to Follow:

      1. Using the exported Excel files, add columns that are needed to address each of the elements being tested:

        • Pass or Fail

        • Results - Common answers are “As expected”, “Failure”, or “Test Script Failure” Always want to answer as expected if it passes not just pass. You have to refer to the requirement of the row.

        • Notes Failure documentation

        • By Whom (Testers initials)

        • Date of the test(s)

        • Notes

      2. Go down the file and verify the conditional action or property being tested behaves as it is intended. Edit checks can be skipped (these will be tested next). Form properties will cover important factors including view/edit rights for roles and field blinding. To make this easier, grant the Administrator role access to switch roles.

      3. Run Auto-validation on the form’s edit checks. The results will be logged and maintained within TrialKit, which can also be exported for filing purposes.

      4. Using the exported role permissions file, verify the user roles have access to the components they need.

      5. Verify the visit schedule windows are displaying as intended based on a sample Registration date.

      6. Any other items to validate will depend on the functions being used in the study. For example:

        • Randomization

        • eConsenting

        • ePRO diaries

        • Product Distribution and Assignments

      NOTE: Some columns may not be part of every test.

      Example of columns added to a validation script:

      ce69d2c1-df71-4adc-961c-18dea28718e5

       

      TrialKit system-level validation

      CDS performs certification testing on all functions in a standardized environment. The underlying functions tested are in the following list. This can be a helpful reference to use in supplier-level validation for your organization, depending on the functions utilized.

      1. User-specific sign in security
      2. User management and access history
      3. Site management
      4. Study user membership
      5. Form Building
      6. Conditional actions
      7. Data Entry
      8. External variables
      9. Subject Form Data Audit
      10. Version Management
      11. Subject Record Management
      12. Visit Schedules and Cohorts
      13. Study Configuration 
      14. Record Review Workflow
      15. Data Exports
      16. Study Management
      17. Report Builder
      18. Query Management
      19. Role Security
      20. Randomization
      21. Action Items
      22. Notifications
      23. Site Documents
      24. Study Documents
      25. Form Field Rendering
      26. Monitor Report
      27. Lab Normals
      28. Importing Data
      29. Study Progress Report
      30. Adjudication
      31. User Preferences
      32. Record Status Report
      33. Field Level Review (SDV)
      34. PDF Exports
      35. Payment Management
      36. Medical Coding
      37. File Uploads and Storage
      38. Wearables Data
      39. Inventory Management
      40. ePRO and eDiaries
      41. Informed Consent
      42. Trial Master File
      43. Dashboard Report
      44. Video Conferencing
      45. Scheduling
      46. TrialKit Drive Automated Exports
      47. Visit Summary Report
      48. CTMS
      49. Signature By Role Management