CATO Associate Regulatory Compliance 1 — Questions and Answers
Question 1: Which agency is responsible for regulating clinical trials in the United States?
- CDC
- NIH
- FDA (Correct answer)
- CMS
Correct answer: FDA
The FDA oversees the conduct of clinical trials to ensure the safety and efficacy of drugs and devices.
Question 2: What is the purpose of Good Clinical Practice (GCP) guidelines?
- To increase drug sales
- To guide marketing strategies
- To protect participant rights and data integrity (Correct answer)
- To lower research budgets
Correct answer: To protect participant rights and data integrity
GCP ensures ethical and scientific quality standards in the design, conduct, and reporting of clinical trials.
Question 3: Which form must be submitted to the FDA before beginning a clinical trial?
- Form 1572
- IND application (Correct answer)
- Protocol deviation form
- Site startup checklist
Correct answer: IND application
The Investigational New Drug (IND) application must be submitted and approved before human testing can begin.
Question 4: What role does an Institutional Review Board (IRB) play in clinical research?
- It manages site staff
- It writes scientific publications
- It oversees funding
- It protects participants' rights and safety (Correct answer)
Correct answer: It protects participants' rights and safety
The IRB reviews and approves study protocols to ensure ethical treatment of participants.
Question 5: How often must IRB continuing reviews be conducted for ongoing studies?
- Every 6 months
- Annually (Correct answer)
- Only at study closure
- Every 5 years
Correct answer: Annually
IRB continuing reviews are typically required annually to maintain ethical oversight of ongoing trials.
Question 6: What is a protocol deviation?
- A new clinical site
- A patient’s voluntary withdrawal
- A change from the approved study plan (Correct answer)
- IRB approval form
Correct answer: A change from the approved study plan
A protocol deviation is any change or departure from the approved study plan, which must be documented and assessed for impact.
CATO Associate Regulatory Compliance 1
Which agency is responsible for regulating clinical trials in the United States?