RAC Clinical Trials and GCP 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, what is the maximum period an IND may remain on clinical hold before the FDA must provide written explanation?
- 30 days (Correct answer)
- 60 days
- 90 days
- 120 days
Correct answer: 30 days
FDA must notify the sponsor in writing of a clinical hold within 30 days of receiving the IND or amendment.
Question 2: Which GCP principle requires that the benefit-to-risk ratio be favorable before a clinical trial begins?
- Autonomy
- Justice
- Beneficence and non-maleficence (Correct answer)
- Veracity
Correct answer: Beneficence and non-maleficence
Beneficence (do good) and non-maleficence (avoid harm) together require a favorable benefit-risk assessment prior to trial initiation.
Question 3: A sponsor receives an SAE report from an investigator on a Saturday. Under 21 CFR 312.32, fatal unexpected SUSARs must be reported to FDA within:
- 7 calendar days (Correct answer)
- 15 calendar days
- 24 hours
- 30 calendar days
Correct answer: 7 calendar days
Fatal or life-threatening unexpected serious adverse drug reactions must be reported to the FDA within 7 calendar days.
Question 4: What term describes the process by which an IRB reviews a study where the only involvement is a minimal-risk survey of adults?
- Full board review
- Expedited review
- Exempt determination (Correct answer)
- Waived consent review
Correct answer: Exempt determination
Research involving minimal risk with anonymous surveys of adults may qualify as exempt from IRB oversight under 45 CFR 46.104.
Question 5: Which document establishes the formal agreement between a sponsor and a CRO, transferring specific IND obligations?
- Clinical Trial Agreement (CTA)
- Quality Agreement
- Written transfer agreement per 21 CFR 312.52 (Correct answer)
- Master Service Agreement (MSA)
Correct answer: Written transfer agreement per 21 CFR 312.52
21 CFR 312.52 requires a written agreement specifying which IND obligations have been transferred from sponsor to CRO.
Question 6: In GCP, source documents are BEST described as:
- CRFs completed by the investigator
- Original records or certified copies from which CRF data are derived (Correct answer)
- Sponsor monitoring logs
- Protocol amendments signed by the PI
Correct answer: Original records or certified copies from which CRF data are derived
Source documents are original records (e.g., hospital charts, lab reports) or certified copies that serve as the basis for CRF entries.
Question 7: When a protocol deviation occurs at a site, the investigator's PRIMARY obligation is to:
- Terminate the affected subject immediately
- Document and report the deviation per protocol and IRB requirements (Correct answer)
- Amend the protocol retroactively
- Notify the FDA within 24 hours
Correct answer: Document and report the deviation per protocol and IRB requirements
Investigators must document protocol deviations and report them according to the protocol requirements and IRB policies.
RAC Clinical Trials and GCP 2
Under 21 CFR Part 312, what is the maximum period an IND may remain on clinical hold before the FDA must provide written explanation?