CRS Clinical Research Regulations Flashcards

What is the key distinction between a Phase II and Phase III clinical trial?

Answer: Phase II assesses preliminary efficacy; Phase III confirms efficacy in a larger population

Phase II trials evaluate preliminary efficacy and further assess safety in a moderate-sized group, while Phase III confirms efficacy and monitors adverse reactions in a large, definitive trial.

Under GCP guidelines, which party is responsible for verifying that a clinical investigator is qualified to conduct a trial?

Answer: Sponsor

The Sponsor is responsible for selecting qualified investigators and confirming their training, resources, and credentials before a trial begins.

What is a protocol deviation in clinical research?

Answer: Any departure from the approved study protocol procedures

A protocol deviation is any departure from the approved study protocol, whether accidental or unavoidable, that must be documented and reported.

Which US regulation addresses financial conflicts of interest for investigators in federally funded research?

Answer: 42 CFR Part 50, Subpart F

42 CFR Part 50, Subpart F requires institutions to identify, manage, and report significant financial conflicts of interest held by investigators on federally funded research.

What is required before enrolling a minor in a clinical trial under federal regulations?

Answer: Parental permission and, where appropriate, the child's assent

Federal regulations require parental or guardian permission and, where appropriate, the minor's own assent before enrolling a child in a clinical trial.

How is an adverse event (AE) defined in a clinical trial?

Answer: Any undesirable medical occurrence in a participant, regardless of causality

An adverse event is any unfavorable or unintended medical occurrence in a clinical trial participant, whether or not considered related to the study treatment.