CRA ICH-GCP Compliance 3

Question 1

Which ICH-GCP section specifically addresses the investigator's responsibilities for investigational product accountability?

Accepted Answer

ICH E6(R2) Section 4.6

Answer

Section 4.6 of ICH E6(R2) outlines the investigator's responsibilities for accountability of the investigational product, including maintenance of accurate records.

Question 2

What is the significance of the 'Declaration of Helsinki' in relation to ICH-GCP guidelines?

Accepted Answer

ICH-GCP was developed with consideration of the ethical principles in the Declaration of Helsinki

Answer

ICH E6(R2) states that the guideline was developed with consideration of current good clinical practices of the EU, Japan, the US, and the ethical principles of the Declaration of Helsinki.

Question 3

Under ICH-GCP, which of the following constitutes an 'essential document'?

Accepted Answer

Documents that individually and collectively permit evaluation of the conduct of a trial and quality of data

Answer

ICH E6(R2) Section 8 defines essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.

Question 4

When an IRB/IEC reviews a clinical trial, what is the primary ethical concern ICH-GCP requires them to address?

Accepted Answer

Safeguarding the rights, safety, and well-being of all trial subjects

Answer

ICH E6(R2) states that the IRB/IEC's primary purpose is to safeguard the rights, safety, and well-being of all trial subjects.

Question 5

In a multi-center trial conducted under ICH-GCP, who is responsible for coordinating safety information across all sites?

Accepted Answer

The sponsor

Answer

The sponsor is responsible for the ongoing safety evaluation of the investigational product and for coordinating and reporting safety information across all participating sites.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA ICH-GCP Compliance 3