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

Drug labeling requirements

Answer

Trial registration

Answer

AE classification

Question 2

What is the purpose of an IND application?

Accepted Answer

Request FDA authorization to test an investigational drug in humans

Answer

Market a drug immediately

Answer

Patent a compound

Answer

Register on ClinicalTrials.gov

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

Only Phase I trials

Answer

Entirely voluntary

Answer

Only sponsor-initiated

Question 4

What is an FDA Warning Letter?

Accepted Answer

An official correspondence citing significant regulatory violations requiring prompt corrective action

Answer

Routine communication

Answer

Drug approval letter

Answer

Successful inspection notification

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

Same thing

Answer

Part 50 is manufacturing, 56 is labeling

Answer

Both are post-marketing

Question 6

What is a clinical hold?

Accepted Answer

An FDA order to delay or suspend a clinical trial due to safety concerns or deficiencies

Answer

Holiday pause

Answer

Manufacturing hold

Answer

Financial freeze