CRS CRS Clinical Research Regulations 1 — Questions and Answers
Question 1: Which federal agency oversees the regulation of clinical trials for drugs and biologics in the US?
- CDC
- NIH
- FDA (Correct answer)
- OHRP
Correct answer: FDA
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?
- General Clinical Protocol
- Good Clinical Practice (Correct answer)
- Global Compliance Program
- Government Clinical Policy
Correct answer: Good Clinical Practice
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?
- IRB waiver
- Sponsor approval
- Informed consent (Correct answer)
- FDA clearance
Correct answer: Informed consent
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?
- Informed Non-Disclosure
- Investigational New Drug (Correct answer)
- Independent Nursing Documentation
- Institutional Network Database
Correct answer: Investigational New Drug
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?
- 21 CFR Part 312
- 45 CFR Part 46 (Correct answer)
- 21 CFR Part 11
- 42 CFR Part 93
Correct answer: 45 CFR Part 46
45 CFR Part 46, known as the Common Rule, establishes federal standards for protecting human research subjects in federally funded studies.
Question 6: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To manage trial finances
- To independently review accumulating safety and efficacy data (Correct answer)
- To recruit participants
- To write the study protocol
Correct answer: To independently review accumulating safety and efficacy data
A DSMB independently reviews accumulating safety and efficacy data to protect participant welfare throughout a trial.
CRS CRS Clinical Research Regulations 1
Which federal agency oversees the regulation of clinical trials for drugs and biologics in the US?