CRP Regulatory Compliance & Guidelines 2 — Questions and Answers
Question 1: Under 21 CFR Part 11, which of the following is a requirement for electronic records used in clinical research?
- Records must be printed and signed within 24 hours
- Electronic records must be the exact equivalent of paper records and include audit trails (Correct answer)
- Electronic signatures require only a username and password with no additional controls
- Paper backup copies must always be maintained alongside electronic records
Correct answer: Electronic records must be the exact equivalent of paper records and include audit trails
21 CFR Part 11 requires that electronic records be the equivalent of paper records and mandates audit trails to track data creation, modification, and deletion.
Question 2: The Declaration of Helsinki primarily applies to which type of research?
- Animal research conducted in pharmaceutical laboratories
- Medical research involving human subjects (Correct answer)
- Environmental impact studies for drug manufacturing
- Post-market surveillance of approved devices only
Correct answer: Medical research involving human subjects
The Declaration of Helsinki is a set of ethical principles by the World Medical Association governing medical research involving human subjects.
Question 3: A sponsor discovers a serious, unexpected adverse drug reaction during a clinical trial. Under FDA regulations, within what timeframe must an IND Safety Report (expedited) be submitted?
- 7 calendar days for fatal/life-threatening; 15 calendar days for others (Correct answer)
- 24 hours for all serious unexpected reactions
- 30 days for all adverse events regardless of severity
- 48 hours for fatal reactions; 30 days for non-fatal serious reactions
Correct answer: 7 calendar days for fatal/life-threatening; 15 calendar days for others
FDA regulations require expedited IND Safety Reports within 7 days for fatal or life-threatening unexpected serious adverse reactions and within 15 days for other unexpected serious adverse reactions.
Question 4: Which regulation establishes the standards for Good Laboratory Practice (GLP) for nonclinical laboratory studies submitted to the FDA?
- 21 CFR Part 50
- 21 CFR Part 58 (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 46
Correct answer: 21 CFR Part 58
21 CFR Part 58 establishes Good Laboratory Practice regulations for nonclinical laboratory studies that support research or marketing permits for FDA-regulated products.
Question 5: What does the concept of 'research misconduct' include under federal regulations (42 CFR Part 93)?
- Only plagiarism of published journal articles
- Fabrication, falsification, and plagiarism in proposing, performing, reviewing, or reporting research (Correct answer)
- Any deviation from approved research protocols, regardless of intent
- Unauthorized use of research funds for unrelated expenses
Correct answer: Fabrication, falsification, and plagiarism in proposing, performing, reviewing, or reporting research
Federal regulations define research misconduct as fabrication, falsification, or plagiarism (FFP) in proposing, performing, reviewing, or reporting research results.
Question 6: An IRB is reviewing a study involving a new survey administered to competent adults with no identifiable information collected. Under 45 CFR 46, this research most likely qualifies for:
- Full board review due to the involvement of human subjects
- Exemption from IRB review under Category 2 (Correct answer)
- Expedited review requiring annual renewal
- Waiver of informed consent only, not IRB review
Correct answer: Exemption from IRB review under Category 2
Research involving surveys or interviews of competent adults where responses are not identifiable typically qualifies for exemption under Category 2 of 45 CFR 46.104.
Question 7: Under ICH E6(R2) GCP guidelines, who is ultimately responsible for the conduct of a clinical trial at a site?
- The sponsor's clinical research associate (CRA)
- The principal investigator (Correct answer)
- The IRB/IEC chairperson
- The data safety monitoring board (DSMB)
Correct answer: The principal investigator
ICH E6(R2) places ultimate responsibility for the conduct of the clinical trial at the site on the principal investigator.
CRP Regulatory Compliance & Guidelines 2
Under 21 CFR Part 11, which of the following is a requirement for electronic records used in clinical research?