CRS CRS Clinical Research Regulations

Question 1

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

Accepted Answer

FDA

Answer

CDC

Answer

NIH

Answer

OHRP

Question 2

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

Accepted Answer

Good Clinical Practice

Answer

General Clinical Protocol

Answer

Global Compliance Program

Answer

Government Clinical Policy

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

IRB waiver

Answer

Sponsor approval

Answer

FDA clearance

Question 4

What is an IND application in clinical research?

Accepted Answer

Investigational New Drug

Answer

Informed Non-Disclosure

Answer

Independent Nursing Documentation

Answer

Institutional Network Database

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

21 CFR Part 312

Answer

21 CFR Part 11

Answer

42 CFR Part 93

Question 6

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

Accepted Answer

To independently review accumulating safety and efficacy data

Answer

To manage trial finances

Answer

To recruit participants

Answer

To write the study protocol