CTA Trial Documentation 3

Question 1

What action must be taken when a protocol amendment changes inclusion/exclusion criteria for already-enrolled subjects?

Accepted Answer

Re-screen all enrolled subjects against new criteria and document the assessment

Answer

An impact assessment for currently enrolled subjects must be conducted and documented whenever eligibility criteria change.

Question 2

Which type of audit trail feature is required in electronic data capture (EDC) systems per 21 CFR Part 11?

Accepted Answer

Time-stamped record of all data entries, changes, and deletions

Answer

21 CFR Part 11 mandates that EDC systems maintain a secure, time-stamped audit trail capturing who changed what data and when.

Question 3

A 'blinded' copy of randomization codes held by an independent party during a trial is referred to as:

Accepted Answer

Sealed randomization list

Answer

A sealed randomization list is kept by an independent party to maintain blinding while allowing emergency unblinding if required.

Question 4

What is the primary purpose of the Trial Master File (TMF)?

Accepted Answer

To serve as the comprehensive repository of all essential trial documents

Answer

The TMF is the definitive collection of all essential documents demonstrating that the trial was conducted in compliance with GCP and regulations.

Question 5

Which document must be updated and re-signed by a subject whenever new safety information materially affects willingness to continue participation?

Accepted Answer

Re-consent form / updated ICF

Answer

When significant new risk information emerges, subjects must be re-consented using an updated informed consent form before continuing.

(CTA) Clinical Trial Associate Certification Practice Test