Audits, Monitoring, and Inspections Flashcards

A Warning Letter from FDA following an inspection is most accurately described as:

Answer: An official communication citing significant violations and requiring a written corrective action response

An FDA Warning Letter identifies significant GCP or regulatory violations and requires the recipient to submit a written response describing corrective actions.

During a trial, who is primarily responsible for ensuring that monitoring is performed?

Answer: The sponsor

ICH E6(R2) and 21 CFR Part 312 place primary responsibility on the sponsor to conduct adequate monitoring to ensure data quality and subject protection.

Which of the following is a key difference between an internal audit and an inspection?

Answer: Internal audits are conducted by the organization itself or a contracted party, while inspections are conducted by regulatory authorities

Internal audits are a quality assurance tool employed by the sponsor or site, whereas inspections are conducted by regulatory authorities such as FDA or EMA.

A site's audit reveals that informed consent forms for 5 subjects were signed after the subjects had already undergone screening procedures. This finding is BEST classified as:

Answer: A serious GCP violation and potential human subjects protection issue

Obtaining consent after procedures begin violates the fundamental GCP principle of informed consent prior to any trial-related activities and constitutes a serious violation.

When preparing for an FDA inspection, a site coordinator should ensure that the Investigator Site File (ISF) contains:

Answer: All essential documents required by ICH E6(R2) Appendix, organized and readily retrievable

The ISF must contain all essential documents per ICH E6(R2) Appendix, organized such that they can be quickly presented to an inspector.

Centralized monitoring activities are performed remotely and may include all of the following EXCEPT:

Answer: Physical verification of investigational product storage temperature

Physical verification of storage conditions, such as checking a freezer log in person, requires an on-site visit and cannot be accomplished through centralized remote monitoring.

According to 21 CFR 312.62, how long must an investigator retain clinical trial records after submitting a final report to the sponsor?

Answer: 2 years

21 CFR 312.62(c) requires investigators to retain records for at least 2 years after the later of the date of approval of the NDA or discontinuation of the IND.