SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 1

Question 1

According to ICH GCP E6(R2), which of the following is a primary responsibility of the clinical trial Sponsor?

Accepted Answer

Selecting qualified investigators and ensuring proper monitoring of the trial.

Answer

ICH GCP E6(R2) Section 5 clearly outlines the sponsor's responsibilities. Section 5.6 specifies that the sponsor is responsible for selecting qualified investigators and institutions. Furthermore, Section 5.18 details the sponsor's responsibility for ensuring adequate trial monitoring to verify the protection of human subjects and the quality of the data. While the investigator is responsible for obtaining consent and ensuring data accuracy at the site, the ultimate oversight and qualification assessment lies with the sponsor.

Question 2

An investigator at a clinical trial site realizes that a study participant was inadvertently enrolled despite not meeting a key inclusion criterion. According to ICH GCP principles, what is the MOST appropriate immediate action for the investigator to take?

Accepted Answer

Take appropriate measures to protect the participant's safety and well-being, document the deviation, and report it to the sponsor and IRB/IEC as required.

Answer

ICH GCP emphasizes the paramount importance of protecting the rights, safety, and well-being of trial subjects. When a protocol deviation like this occurs, the investigator's first priority is the subject's safety. The investigator must then document the deviation and report it to the sponsor and the IRB/IEC according to their respective policies and regulatory requirements to ensure transparency and proper oversight.

Question 3

Which of the following documents must be on file at the investigational site BEFORE the clinical phase of a trial begins?

Accepted Answer

A signed and dated protocol, current Investigator's Brochure, and IRB/IEC approval.

Answer

ICH GCP E6(R2) Section 8.2 outlines the essential documents required before the clinical phase of a trial commences. These include a signed protocol agreed upon by the investigator and sponsor, the current Investigator's Brochure containing all relevant information about the investigational product, and documented approval from the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the protocol and informed consent form.

Question 4

During the informed consent process, the investigator must ensure that the potential participant understands all of the following EXCEPT:

Accepted Answer

The complete formulation and manufacturing process of the investigational product.

Answer

ICH GCP E6(R2) Section 4.8.10 details the elements that must be included in the informed consent discussion and form. These elements focus on ensuring the participant can make a voluntary and informed decision. They include the study's purpose, procedures, risks, benefits, and the voluntary nature of participation. While the Investigator's Brochure provides detailed product information to the investigator, the complete proprietary manufacturing process is not a required element for the participant's informed consent.

Question 5

Source data in a clinical trial, as defined by ICH GCP, must be ALCOA-C. What does the 'C' in this acronym stand for?

Accepted Answer

Complete

Answer

The acronym ALCOA-C (or ALCOA+) refers to the standards for high-quality data. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. 'Complete' means that the data includes all pertinent observations for that subject, without missing information.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 1