Now that you have completed building your study, it is time for User Acceptance Testing.
User Acceptance Testing, or UAT, is one element of your validation process. UAT should test for both positive and negative results, and you should begin with a plan for what and how you will test each field.
Before starting UAT, we recommend that you perform a basic quality check of your CRFs.
To assist you with testing, we have compiled a checklist of the items you may want to test for your study.
A sample UAT Protocol is included in this article below. It contains a few items that you may want to test for validation, as well as some of the phases/steps for UAT. Please replace the necessary items with items from your study and update any other requirements for your organization.
Please note, that this checklist and sample UAT Protocol may not cover all studies so if you have any questions, please contact support for assistance.
| Test Setup | |
|---|---|
| □ | Castor Database Created |
| □ | Test Site Created |
| □ | Users (roles) Created |
| Test Procedure | |
| □ | Identify all visits and forms |
| □ | Identify all repeating data |
| □ | Identify all surveys |
| Test Cases | |
| □ | Create test case |
| □ | Test cases should include: |
| □ | Logging into EDC/CDMS |
| □ | Lock out of EDC/CDMS |
| □ | Time out of EDC/CDMS |
| □ | Creating a new participant |
| □ | Check autonumbering of participants |
| □ | Completion of each visit and form identified above |
| □ | Data validations (appear and disappear) |
| □ | Dependent fields, including add a repeating data buttons, remark fields, repeated measure fields (trigger and clear) |
| □ | Calculation fields |
| □ | Verify GCP warning on edited data |
| □ | Audit trail |
| □ | Monitoring |
| □ | Signing and Locking |
| □ | Verify errors on empty required fields |
| □ | Randomization |
| If Applicable | |
| □ | Sending surveys |
| □ | Automations |
| □ | Hiding visits/forms |
| □ | Queries |
| □ | Sending surveys |
For more information on developing your UAT protocol, we suggest the following reading material:
- FDA CDRH 938, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
- Good Clinical Data Management Practices (GCDMP©)
- 21 CFR Part 11, Electronic Records
- 21 CFR Part 820, Quality System Regulation (QSR)
The UAT Report template can be downloaded below: