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:



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