CATO Associate Regulatory Compliance

Question 1

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

Accepted Answer

FDA

Answer

CDC

Answer

NIH

Answer

CMS

Question 2

What is the purpose of Good Clinical Practice (GCP) guidelines?

Accepted Answer

To protect participant rights and data integrity

Answer

To increase drug sales

Answer

To guide marketing strategies

Answer

To lower research budgets

Question 3

Which form must be submitted to the FDA before beginning a clinical trial?

Accepted Answer

IND application

Answer

Form 1572

Answer

Protocol deviation form

Answer

Site startup checklist

Question 4

What role does an Institutional Review Board (IRB) play in clinical research?

Accepted Answer

It protects participants' rights and safety

Answer

It manages site staff

Answer

It writes scientific publications

Answer

It oversees funding

Question 5

How often must IRB continuing reviews be conducted for ongoing studies?

Accepted Answer

Annually

Answer

Every 6 months

Answer

Only at study closure

Answer

Every 5 years

Question 6

What is a protocol deviation?

Accepted Answer

A change from the approved study plan

Answer

A new clinical site

Answer

A patient’s voluntary withdrawal

Answer

IRB approval form