CRS CRS Clinical Research Regulations 1

Question 1

Which federal agency oversees the regulation of clinical trials for drugs and biologics in the US?

Accepted Answer

FDA

Answer

The FDA regulates clinical trials for drugs, biologics, and medical devices in the United States.

Question 2

What does GCP stand for in the context of clinical research?

Accepted Answer

Good Clinical Practice

Answer

GCP (Good Clinical Practice) is an international ethical and scientific quality standard for designing, conducting, and reporting clinical trials.

Question 3

Under 21 CFR Part 50, which of the following is required before a subject can participate in a clinical trial?

Accepted Answer

Informed consent

Answer

21 CFR Part 50 mandates that informed consent be obtained from all participants before enrollment in a clinical trial.

Question 4

What is an IND application in clinical research?

Accepted Answer

Investigational New Drug

Answer

An IND (Investigational New Drug) application must be filed with the FDA before testing a new drug in human subjects.

Question 5

Which federal regulation (the 'Common Rule') governs the protection of human subjects in federally funded research?

Accepted Answer

45 CFR Part 46

Answer

45 CFR Part 46, known as the Common Rule, establishes federal standards for protecting human research subjects in federally funded studies.

(CRS) Certified Research Specialist Practice Test