SOCRA - Society of Clinical Research Associates FDA Regulations and Compliance Questions and Answers 2

Question 1

What is 21 CFR Part 11?

Accepted Answer

Requirements for electronic records and electronic signatures to be trustworthy and equivalent to paper

Answer

21 CFR Part 11 establishes criteria for electronic records and signatures to be trustworthy and equivalent to paper.

Question 2

What is the purpose of an IND application?

Accepted Answer

Request FDA authorization to test an investigational drug in humans

Answer

An IND requests authorization to begin clinical trials with an investigational drug in humans.

Question 3

What are clinical trial registration requirements under FDAAA 801?

Accepted Answer

Applicable clinical trials must be registered on ClinicalTrials.gov with results reporting

Answer

FDAAA Section 801 requires applicable clinical trials to be registered and submit results within specified timeframes.

Question 4

What is an FDA Warning Letter?

Accepted Answer

An official correspondence citing significant regulatory violations requiring prompt corrective action

Answer

A Warning Letter identifies significant violations that may lead to enforcement action if not corrected.

Question 5

What is the difference between 21 CFR 50 and 21 CFR 56?

Accepted Answer

Part 50 governs informed consent; Part 56 governs IRBs

Answer

Part 50 covers informed consent requirements; Part 56 covers IRB composition, operations, and responsibilities.

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