CCRA Regulatory Compliance and ICH-GCP

Question 1

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

Accepted Answer

ICH E6(R2)

Answer

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?

Accepted Answer

Written Transfer of Obligations

Answer

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?

Accepted Answer

21 CFR Part 56

Answer

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?

Accepted Answer

7 calendar days

Answer

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:

Accepted Answer

Genuine uncertainty about which treatment is superior

Answer

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.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Regulatory Compliance and ICH-GCP