CCRA Regulatory Compliance and ICH-GCP 3

Question 1

ICH E6(R2) defines 'essential documents' as those that individually and collectively permit evaluation of the conduct of a trial and:

Accepted Answer

The quality of the data produced

Answer

Essential documents allow evaluation of both the conduct of the trial and the quality of data generated, and are required to be maintained throughout and after the trial.

Question 2

In the US, a sponsor must submit an IND application to the FDA before:

Accepted Answer

Both B and C

Answer

An IND must be submitted before shipping investigational drug and before initiating a clinical trial in human subjects in the United States.

Question 3

Which GCP principle states that the rights, safety, and well-being of trial subjects are the most important considerations?

Accepted Answer

Ethical principle of primacy of subject protection

Answer

ICH E6(R2) principle 2.3 explicitly states that the rights, safety, and well-being of trial subjects must prevail over the interests of science and society.

Question 4

What is the primary purpose of a Form FDA 1572 (Statement of Investigator)?

Accepted Answer

To document the investigator's commitments and qualifications to conduct the trial per FDA regulations

Answer

FDA Form 1572 is a legal agreement in which the investigator commits to conducting the trial per the protocol, GCP, and applicable regulations, and lists key personnel and IRB information.

Question 5

Which document type serves as the definitive guide for CRAs on how to perform site visits for a specific trial?

Accepted Answer

Monitoring Plan

Answer

The Monitoring Plan specifies the monitoring strategy, methodology, responsibilities, and procedures to be followed during trial monitoring visits.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Regulatory Compliance and ICH-GCP 3