Regulatory Compliance and ICH-GCP Flashcards

Which Belmont Report principle requires that the benefits of research be maximized and harms minimized?

Answer: Beneficence

The principle of beneficence obligates researchers to maximize possible benefits and minimize possible harms when conducting research with human subjects.

A CRA discovers that a site has been using an expired version of the informed consent form. What is the MOST immediate action?

Answer: Document the finding and require re-consent using the current IRB-approved form

The CRA must document the deviation and work with the site to re-consent affected subjects using the current approved form, while reporting to the sponsor per the monitoring plan.

Under ICH-GCP E6(R2), the sponsor's audit differs from monitoring in that audits are:

Answer: Systematic independent evaluations to assess trial conduct

Audits under ICH E6(R2) are systematic, independent examinations of trial-related activities and documents to evaluate whether the trial is conducted per the protocol, SOPs, GCP, and regulations.

A 'Certificate of Analysis' (CoA) for investigational product is used primarily to verify:

Answer: Drug identity, purity, potency, and quality

A CoA documents that the investigational product meets specified quality attributes including identity, purity, potency, and other release specifications.

Which regulation requires informed consent to be obtained in a language understandable to the subject?

Answer: 21 CFR Part 50

21 CFR Part 50 specifies that the information given to subjects must be in language understandable to the subject or their legally authorized representative.

A 'Competent Authority' in the context of EU clinical trial regulations refers to:

Answer: A national regulatory body such as the MHRA or BfArM

A Competent Authority is the national regulatory agency responsible for authorizing clinical trials in a given EU member state, such as the MHRA in the UK or BfArM in Germany.