SOCRA CCRP Regulatory Compliance 1

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

45 CFR Part 46, known as the Common Rule, is the federal regulation governing protection of human subjects in federally funded research.

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

21 CFR Part 312 establishes FDA requirements for IND applications, including sponsor and investigator responsibilities.

Question 3

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

Accepted Answer

ICH E6

Answer

ICH E6 (R2) is the international GCP guideline that establishes standards for the design, conduct, and reporting of clinical trials.

Question 4

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

Accepted Answer

The Principal Investigator

Answer

Form FDA 1572 is the Statement of Investigator that must be signed by the Principal Investigator, committing to GCP compliance.

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

Per 21 CFR Part 312.62, records must be retained for 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Regulatory Compliance 1