SOCRA CCRP Regulatory Compliance

Question 1

Which US federal regulation governs the protection of human subjects in research conducted or supported by federal departments?

Accepted Answer

45 CFR Part 46

Answer

21 CFR Part 50

Answer

21 CFR Part 312

Answer

45 CFR Part 164

Question 2

What is the primary purpose of 21 CFR Part 312 in clinical research?

Accepted Answer

To establish requirements for Investigational New Drug (IND) applications

Answer

To regulate laboratory testing standards

Answer

To govern IRB operations

Answer

To define Good Laboratory Practice

Question 3

Which ICH guideline defines Good Clinical Practice (GCP) standards internationally?

Accepted Answer

ICH E6

Answer

ICH E3

Answer

ICH E9

Answer

ICH E10

Question 4

A Form FDA 1572 is required to be signed by which individual?

Accepted Answer

The Principal Investigator

Answer

The IRB Chairperson

Answer

The Sponsor's Medical Monitor

Answer

The CRO Project Manager

Question 5

Under FDA regulations, how long must an investigator retain clinical trial records after the investigation is discontinued or completed?

Accepted Answer

3 years

Answer

2 years

Answer

5 years

Answer

7 years

Question 6

What does 'regulatory binder' typically contain at a clinical research site?

Accepted Answer

Essential documents required by ICH GCP and FDA regulations

Answer

Lab results and patient diaries

Answer

Sponsor invoices and budget agreements

Answer

Patient enrollment logs only