RAC Clinical Trials and GCP Questions and Answers 1

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

The fundamental purpose of an IRB is to protect the rights and welfare of human research subjects. While scientific design is reviewed to assess the risk/benefit ratio, the IRB's primary mandate is the ethical oversight and protection of participants, not statistical validation, data verification, or financial auditing.

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

FDA regulations require expedited reporting for serious and unexpected suspected adverse reactions. For events that are fatal or life-threatening, the sponsor must notify the FDA within 7 calendar days. The 15-day timeline applies to other serious, unexpected suspected adverse reactions.

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

ICH E6 Section 8 divides essential documents into three phases: before, during, and after the trial. The Investigator's Brochure, which contains a summary of the clinical and nonclinical data on the investigational product, must be on file at the investigator site before the trial begins to inform the investigator and staff.

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

Source Data Verification (SDV) is the process of checking the data transcribed into the Case Report Forms (CRFs) against the original source documents to ensure the data is accurate, complete, and verifiable.

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

According to ICH GCP, while a sponsor may transfer trial-related duties and functions to a CRO, the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The sponsor must ensure oversight of any delegated functions.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Clinical Trials and GCP Questions and Answers 1