Regulatory Compliance and ICH-GCP Flashcards

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

Answer: The quality of the data produced

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.

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

Answer: Both B and C

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

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

Answer: Ethical principle of primacy of subject protection

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.

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

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

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.

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

Answer: Monitoring Plan

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

When a protocol amendment requires IRB approval before implementation, who is responsible for ensuring the amendment is approved prior to implementation at the site?

Answer: The Sponsor

The sponsor is responsible for submitting protocol amendments to the FDA and ensuring IRB approval is in place before the amended protocol is implemented at investigational sites.