Regulatory Compliance and ICH-GCP Flashcards

Which ICH-GCP guideline governs the conduct of clinical trials to ensure data integrity and subject safety?

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.

Under FDA regulations, which document defines the sponsor's delegation of trial-related duties to a CRO?

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.

Which US regulation specifically governs Institutional Review Board (IRB) requirements for FDA-regulated clinical trials?

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.

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?

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.

The principle of 'equipoise' in clinical research ethics means:

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.

When a site in the US enrolls a subject without a valid IRB approval, the CRA should first:

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.