CCRA Regulatory Compliance and ICH-GCP 1 — Questions and Answers
Question 1: Which ICH-GCP guideline governs the conduct of clinical trials to ensure data integrity and subject safety?
- ICH E6(R2) (Correct answer)
- ICH E8
- ICH E9
- ICH E3
Correct answer: ICH E6(R2)
ICH E6(R2) is the Good Clinical Practice guideline that establishes international standards for designing, conducting, recording, and reporting trials involving human subjects.
Question 2: Under FDA regulations, which document defines the sponsor's delegation of trial-related duties to a CRO?
- Clinical Trial Agreement
- Monitoring Plan
- Written Transfer of Obligations (Correct answer)
- Protocol Amendment
Correct answer: Written Transfer of Obligations
21 CFR Part 312 requires a written transfer of obligations document when a sponsor transfers any trial duties to a CRO.
Question 3: Which US regulation specifically governs Institutional Review Board (IRB) requirements for FDA-regulated clinical trials?
- 21 CFR Part 50
- 21 CFR Part 56 (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 46
Correct answer: 21 CFR Part 56
21 CFR Part 56 sets forth the requirements for IRB composition, operations, and review of clinical investigations regulated by the FDA.
Question 4: What is the maximum time frame the FDA allows for a sponsor to submit an IND safety report for an unexpected fatal or life-threatening SUSAR?
- 7 calendar days (Correct answer)
- 15 calendar days
- 30 calendar days
- 24 hours
Correct answer: 7 calendar days
Under 21 CFR 312.32, unexpected fatal or life-threatening suspected unexpected serious adverse reactions must be reported to the FDA within 7 calendar days.
Question 5: The principle of 'equipoise' in clinical research ethics means:
- Equal randomization of subjects
- Genuine uncertainty about which treatment is superior (Correct answer)
- Equal compensation for all participants
- Balanced placebo-to-treatment ratio
Correct answer: Genuine uncertainty about which treatment is superior
Clinical equipoise refers to genuine uncertainty in the expert medical community about the comparative merits of treatments being studied, justifying the ethical conduct of a trial.
Question 6: When a site in the US enrolls a subject without a valid IRB approval, the CRA should first:
- Immediately terminate the site
- Notify the sponsor and document the protocol deviation (Correct answer)
- Instruct the site to re-consent the subject
- Report directly to the FDA without sponsor notification
Correct answer: Notify the sponsor and document the protocol deviation
The CRA must notify the sponsor and document the deviation per the monitoring plan; the sponsor then determines escalation steps including possible regulatory reporting.
CCRA Regulatory Compliance and ICH-GCP 1
Which ICH-GCP guideline governs the conduct of clinical trials to ensure data integrity and subject safety?