CCDM Computer System Validation

Question 1

What is the purpose of User Acceptance Testing (UAT) of an EDC study build?

Accepted Answer

To confirm the built database and edit checks work as specified before go-live

Answer

UAT confirms the study-specific configuration, including forms, edit checks and derivations, meets the requirements. It is done before the study goes live.

Question 2

Which sequence correctly describes the qualification steps used in computer system validation?

Accepted Answer

IQ, OQ, PQ

Answer

Installation Qualification confirms correct installation, Operational Qualification confirms functions work to specification, and Performance Qualification confirms performance under real conditions.

Question 3

Which document links each user requirement to the tests that verify it?

Accepted Answer

Traceability matrix

Answer

A requirements traceability matrix maps requirements to design and test cases, which shows that every requirement was tested.

Question 4

A new software version is released for a validated system during an ongoing study. What should happen?

Accepted Answer

Perform change control with impact assessment and appropriate re-validation/regression testing

Answer

Changes to a validated system need documented change control, a risk-based impact assessment and testing to show the system stays in a validated state.

Question 5

Which feature is required for electronic records used in regulated trials under 21 CFR Part 11 principles?

Accepted Answer

Secure, computer-generated, time-stamped audit trails

Answer

Systems must keep secure, time-stamped audit trails that record who changed what and when, without obscuring earlier values. They must also use unique logins.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Computer System Validation