RAC Clinical Trials and GCP 3

Question 1

Which ICH E6(R2) addendum requirement was specifically added to strengthen sponsor oversight of clinical trial quality?

Accepted Answer

Risk-based monitoring (RBM) and Quality Management Systems (QMS)

Answer

ICH E6(R2) introduced requirements for risk-based monitoring and a quality management system approach to identify and address critical data and process risks.

Question 2

A subject enrolled in a Phase II oncology trial dies unexpectedly. The investigator believes the death is unrelated to the study drug. Which action is required first?

Accepted Answer

Notify the IRB within 24 hours and the sponsor immediately

Answer

Any unexpected subject death must be reported to the IRB promptly (typically within 24 hours) and to the sponsor immediately per GCP and protocol requirements.

Question 3

Under 21 CFR 50.25, which element of informed consent addresses what happens if a subject is injured during research?

Accepted Answer

Compensation and treatment available for injury

Answer

21 CFR 50.25(a)(6) requires that consent explain whether compensation or medical treatment is available if injury occurs.

Question 4

The 'intention-to-treat' (ITT) population in a clinical trial refers to:

Accepted Answer

All randomized subjects analyzed in the group to which they were assigned

Answer

ITT analysis includes all randomized subjects analyzed according to their original treatment assignment, regardless of protocol adherence.

Question 5

A Data Safety Monitoring Board (DSMB) is MOST commonly used in clinical trials to:

Accepted Answer

Provide independent interim review of accumulating safety and efficacy data

Answer

A DSMB independently reviews unblinded interim data to recommend continuation, modification, or early stopping of a trial based on safety or efficacy.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Clinical Trials and GCP 3