Study Validation and User Acceptance

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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.

This article will cover what TrialKit can provide directly to help you with documenting the study design and using that documentation to validate against.

It’s important to consider that TrialKit’s functions are all validated at a system level under a common use-case and can be guaranteed by CDS to function appropriately. The value in covering many of the steps outlined here is not to verify that a specific function works, but rather to verify the various settings are functioning as the study design requires. It also helps catch some settings that may have been unintentionally missed or misunderstood.

What to export:

Study roles and permissions
Data Dictionaries (be sure to export the applicable version if the study there is more than one)
- Form Properties
- Conditional Actions
- Field Properties
A Complete PDF Casebook
Screenshot of the visit schedule design

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:

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
- Issue Tracking ID - Track a report of the issue
- By Whom (Testers initials)
- Date of the test(s)
- Notes
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.
Run Auto-validation on the form’s edit checks. The results with be logged and maintained within TrialKit, which can also be exported for filing purposes.
Using the exported role permissions file, verify the user roles have access to the components they need.
Verify the visit schedule windows are displaying as intended based on a sample Registration date.
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 are not part of every test.

Example of columns added to a validation script: