CATO Associate Regulatory Compliance

Question 1

Which agency is responsible for regulating clinical trials in the United States?

Accepted Answer

FDA

Answer

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?

Accepted Answer

To protect participant rights and data integrity

Answer

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?

Accepted Answer

IND application

Answer

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?

Accepted Answer

It protects participants' rights and safety

Answer

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?

Accepted Answer

Annually

Answer

IRB continuing reviews are typically required annually to maintain ethical oversight of ongoing trials.

(CCA) CATO Certified Associate Practice Test