SOCRA - Society of Clinical Research Associates FDA Regulations and Compliance Questions and Answers 2 — Questions and Answers
Question 1: What is 21 CFR Part 11?
- Drug labeling requirements
- Requirements for electronic records and electronic signatures to be trustworthy and equivalent to paper (Correct answer)
- Trial registration
- AE classification
Correct answer: Requirements for electronic records and electronic signatures to be trustworthy and equivalent to paper
21 CFR Part 11 establishes criteria for electronic records and signatures to be trustworthy and equivalent to paper.
Requirements include system validation, accurate copies, record protection, limited access, secure audit trails, operational checks, authority checks, and unique user IDs. Applies to any FDA-required records in electronic format.
Question 2: What is the purpose of an IND application?
- Market a drug immediately
- Request FDA authorization to test an investigational drug in humans (Correct answer)
- Patent a compound
- Register on ClinicalTrials.gov
Correct answer: Request FDA authorization to test an investigational drug in humans
An IND requests authorization to begin clinical trials with an investigational drug in humans.
The IND (21 CFR 312) must contain animal data, manufacturing information (CMC), and clinical protocols. It goes into effect after 30 days unless placed on clinical hold. Types: Commercial, Research, Emergency Use.
Question 3: What are clinical trial registration requirements under FDAAA 801?
- Only Phase I trials
- Applicable clinical trials must be registered on ClinicalTrials.gov with results reporting (Correct answer)
- Entirely voluntary
- Only sponsor-initiated
Correct answer: Applicable clinical trials must be registered on ClinicalTrials.gov with results reporting
FDAAA Section 801 requires applicable clinical trials to be registered and submit results within specified timeframes.
Registration within 21 days of first enrollment. Results within one year of primary completion. Non-compliance can result in penalties up to $10,000/day and withholding of NIH funding.
Question 4: What is an FDA Warning Letter?
- Routine communication
- An official correspondence citing significant regulatory violations requiring prompt corrective action (Correct answer)
- Drug approval letter
- Successful inspection notification
Correct answer: An official correspondence citing significant regulatory violations requiring prompt corrective action
A Warning Letter identifies significant violations that may lead to enforcement action if not corrected.
Issued when Form 483 responses are inadequate or violations are serious. Implications include public posting, potential investigator disqualification, clinical hold, application refusal, debarment, and criminal prosecution.
Question 5: What is the difference between 21 CFR 50 and 21 CFR 56?
- Same thing
- Part 50 governs informed consent; Part 56 governs IRBs (Correct answer)
- Part 50 is manufacturing, 56 is labeling
- Both are post-marketing
Correct answer: Part 50 governs informed consent; Part 56 governs IRBs
Part 50 covers informed consent requirements; Part 56 covers IRB composition, operations, and responsibilities.
Part 50: consent requirements, documentation, required elements, exceptions. Part 56: IRB membership, functions, operations, approval criteria, review procedures, records, compliance. Together they protect human research subjects.
Question 6: What is a clinical hold?
- Holiday pause
- An FDA order to delay or suspend a clinical trial due to safety concerns or deficiencies (Correct answer)
- Manufacturing hold
- Financial freeze
Correct answer: An FDA order to delay or suspend a clinical trial due to safety concerns or deficiencies
A clinical hold (21 CFR 312.42) is an FDA order to delay or suspend a clinical investigation.
Grounds include unreasonable risk, unqualified investigators, misleading IB, and fundamentally flawed protocol design. FDA must provide written explanation within 30 days. All issues must be addressed before the hold is lifted.
