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

Obtaining informed consent from trial participants.

Answer

Making medical decisions for subjects during the trial.

Answer

Ensuring the accuracy of source data at the investigational site.

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

Continue the participant in the trial but exclude their data from the final analysis.

Answer

Inform the participant that they are being withdrawn from the study and document the event.

Answer

Wait for the next monitoring visit to discuss the issue with the Clinical Research Associate (CRA).

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

Final clinical study report.

Answer

Completed Case Report Forms for all enrolled subjects.

Answer

Monitoring visit reports and follow-up letters.

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

That the trial involves research and the purpose of the trial.

Answer

The trial procedures, foreseeable risks, and potential benefits.

Answer

That their participation is voluntary and they may withdraw at any time.

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

Certified

Answer

Contemporaneous

Answer

Confidential

Question 6

Which entity is responsible for safeguarding the rights, safety, and well-being of all trial subjects and must review and approve the clinical trial protocol and informed consent form before the study begins?

Accepted Answer

The Institutional Review Board / Independent Ethics Committee (IRB/IEC)

Answer

The Sponsor

Answer

The lead Clinical Research Associate (CRA)

Answer

The regulatory authority (e.g., FDA)