Regulatory Compliance and GCP Flashcards

Which FDA regulation outlines requirements for the conduct of Investigational New Drug (IND) studies?

Answer: 21 CFR Part 312

21 CFR Part 312 governs the IND application process, including requirements for study design, sponsor responsibilities, and investigator obligations.

What is the role of the Data Safety Monitoring Board (DSMB) in a clinical trial?

Answer: To independently review accumulating safety and efficacy data at planned intervals

A DSMB is an independent group that reviews unblinded accumulating data to ensure participant safety and study integrity, recommending continuation, modification, or stopping.

Under GCP, which document must a subject sign before participating in a clinical trial?

Answer: Informed consent form

GCP requires that each participant sign an IRB/IEC-approved informed consent form prior to any study procedures, ensuring voluntary and informed participation.

What is a 'protocol deviation' in clinical research?

Answer: Any departure from the approved study protocol that is not pre-approved

A protocol deviation is any unplanned, unapproved departure from the study protocol that may or may not affect subject safety or data integrity.

Which agency publishes the FDA Bioresearch Monitoring (BIMO) guidance for clinical data management?

Answer: FDA Center for Drug Evaluation and Research (CDER)

The FDA's CDER publishes BIMO guidance documents that outline inspection expectations for clinical investigators, sponsors, monitors, and IRBs.

What is the purpose of a Trial Master File (TMF) in clinical research?

Answer: To collect and archive all essential documents that allow evaluation of trial conduct and data quality

The TMF is a comprehensive collection of essential documents demonstrating that a trial was conducted in compliance with GCP, protocols, and applicable regulations.