RAC Clinical Trials and GCP 4

Question 1

A clinical trial site is using an electronic data capture (EDC) system. Under 21 CFR Part 11, audit trails must be:

Accepted Answer

Computer-generated, time-stamped, and operator-independent

Answer

21 CFR Part 11 requires that audit trails be computer-generated, secure, time-stamped, and created independently without operator intervention.

Question 2

Which of the following is an example of a 'per-protocol' (PP) analysis population?

Accepted Answer

Subjects who completed the trial with no major protocol deviations

Answer

The per-protocol population includes only subjects who fully complied with the protocol, providing an estimate of efficacy under ideal conditions.

Question 3

Under 21 CFR 312.62, how long must an investigator retain clinical trial records after the IND is terminated or the investigation is discontinued?

Accepted Answer

2 years

Answer

Investigators must retain study records for at least 2 years after the date of approval of the NDA or, if no application is filed, 2 years after the investigation is discontinued.

Question 4

A subject in a blinded trial accidentally discovers their treatment assignment. Under GCP, this event should be classified as:

Accepted Answer

An unplanned unblinding or protocol deviation

Answer

Accidental unblinding is a protocol deviation that must be documented and reported according to protocol and IRB requirements.

Question 5

Which regulatory requirement mandates that clinical investigators submit a financial disclosure to the sponsor?

Accepted Answer

21 CFR Part 54

Answer

21 CFR Part 54 requires investigators to disclose financial interests that may affect the reliability of clinical study data submitted to FDA.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Clinical Trials and GCP 4