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

IRB

Answer

NIH

Answer

DEA

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 pause in patient enrollment requested by the IRB

Answer

A temporary halt due to site staffing issues

Answer

A sponsor-initiated pause for protocol amendments

Question 3

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

Accepted Answer

Pregnant women, prisoners, and children

Answer

Employees of the sponsor

Answer

Elderly individuals over 65

Answer

Non-English speaking participants

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

To protect sponsor proprietary data from competitors

Answer

To certify that a site maintains data confidentiality standards

Answer

To exempt the study from HIPAA requirements

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 11

Answer

21 CFR Part 50

Answer

21 CFR Part 312

Question 6

A sponsor submits an IND to the FDA. If the FDA does not respond within how many days, the sponsor may proceed with the trial?

Accepted Answer

30 days

Answer

14 days

Answer

21 days

Answer

45 days