SOCRA CCRP Regulatory Compliance 2

Question 1

Which regulatory body must approve a new drug's IND before Phase 1 clinical trials can begin in the US?

Accepted Answer

FDA

Answer

The FDA must receive and approve (or allow 30 days to pass without clinical hold) an IND before Phase 1 trials can begin in the US.

Question 2

What is a 'clinical hold' in the context of FDA regulations?

Accepted Answer

An FDA order to delay or suspend a clinical investigation

Answer

A clinical hold is an FDA order to delay a proposed or suspend an ongoing clinical investigation based on safety or compliance concerns.

Question 3

Under 21 CFR Part 50, which individuals are considered 'vulnerable' populations requiring additional protections?

Accepted Answer

Pregnant women, prisoners, and children

Answer

21 CFR Part 50 subparts C and D provide additional protections for children and prisoners as vulnerable populations.

Question 4

What is the purpose of a Certificate of Confidentiality (CoC) in US clinical research?

Accepted Answer

To protect researchers from being compelled to disclose identifiable research information

Answer

A Certificate of Confidentiality protects identifiable, sensitive research information from compelled disclosure in legal, administrative, or other proceedings.

Question 5

Which section of the Code of Federal Regulations addresses IRB composition and review procedures?

Accepted Answer

21 CFR Part 56

Answer

21 CFR Part 56 covers IRB regulations, including composition, functions, operations, and review criteria.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Regulatory Compliance 2