RAC Clinical Trials and GCP Questions and Answers

Question 1

An Institutional Review Board (IRB) is reviewing a protocol for a Phase 3 clinical trial. According to ICH GCP, which of the following is the PRIMARY responsibility of the IRB?

Accepted Answer

Protecting the rights, safety, and well-being of the human subjects participating in the trial.

Answer

Ensuring the scientific validity and statistical robustness of the trial design.

Answer

Verifying the accuracy of the data collected at the clinical sites.

Answer

Confirming the sponsor has adequate financial resources to complete the study.

Question 2

A clinical trial investigator at a site becomes aware of a serious adverse event (SAE) that is both unexpected and fatal. According to FDA regulations (21 CFR 312.32), what is the sponsor's reporting obligation to the FDA?

Accepted Answer

The sponsor must report the fatal, unexpected suspected adverse reaction to the FDA as soon as possible, but no later than 7 calendar days after the sponsor's initial receipt of the information.

Answer

The sponsor must report the event to the FDA within 30 calendar days.

Answer

The sponsor must report the event to the FDA as soon as possible, but no later than 15 calendar days after initial receipt of the information.

Answer

The sponsor is only required to report the event in the annual safety report.

Question 3

Which of the following documents is considered an "Essential Document" that must be maintained at the investigator site BEFORE the clinical phase of a trial commences, according to ICH E6?

Accepted Answer

The Investigator's Brochure.

Answer

The final clinical study report.

Answer

Signed subject informed consent forms.

Answer

All serious adverse event reports.

Question 4

During a monitoring visit, a Clinical Research Associate (CRA) compares the data entered into the electronic Case Report Forms (eCRFs) with the original medical records and lab results. This process is known as:

Accepted Answer

Source Data Verification (SDV)

Answer

Informed Consent Review

Answer

Protocol Amendment Submission

Answer

Adverse Event Adjudication

Question 5

A sponsor delegates the responsibility for clinical trial monitoring to a Contract Research Organization (CRO). Under ICH GCP guidelines, who holds the ultimate responsibility for the quality and integrity of the trial data?

Accepted Answer

The Sponsor, as they cannot delegate ultimate responsibility.

Answer

The CRO, because they are contracted to perform the monitoring.

Answer

The Principal Investigator at each clinical site.

Answer

The Institutional Review Board (IRB) that approved the study.

Question 6

According to 21 CFR 50.25, which of the following is a required basic element of informed consent?

Accepted Answer

A statement that participation is voluntary and the subject may discontinue participation at any time without penalty.

Answer

A detailed biography of the principal investigator.

Answer

The complete financial disclosure of the study sponsor.

Answer

A guarantee that the subject will receive personal benefit from participating in the research.