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Performing User Acceptance Testing (UAT)

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 Institute Created
   □
Users (roles) Created
Test Procedure
Identify all phases and steps
Identify all reports
Identify all surveys
Test Cases
Create test case
Test cases should include:
Logging into EDC
Lock out of EDC
Time out of EDC
Creating a new record
Check autonumbering of records
Completion of each phase and step identified above
Data validations (appear and disappear)

Dependent fields, including add a report 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 phases/steps
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)

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  1. Castor Support Team

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