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

Increased IRB meeting frequency

Answer

Mandatory site audits every 6 months

Answer

Real-time electronic CRF submission to FDA

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

Close the site pending investigation

Answer

Amend the informed consent form

Answer

File a MedWatch report directly to FDA

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

Purpose of research

Answer

Anticipated duration of participation

Answer

Confidentiality procedures

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

Only subjects who completed all protocol visits

Answer

Subjects who met all inclusion/exclusion criteria

Answer

Subjects with no major protocol deviations

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

Audit CRF data for accuracy

Answer

Approve protocol amendments

Answer

Certify investigator qualifications

Question 6

Under ICH E6, which party is ultimately responsible for the conduct of a clinical trial?

Accepted Answer

The sponsor

Answer

The IRB/IEC

Answer

The principal investigator

Answer

The regulatory authority

Question 7

Which FDA phase typically involves the LARGEST number of human subjects to establish efficacy and monitor adverse reactions in a general population?

Accepted Answer

Phase III

Answer

Phase I

Answer

Phase II

Answer

Phase IV