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 E8

Answer

ICH E9

Answer

ICH E3

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

Clinical Trial Agreement

Answer

Monitoring Plan

Answer

Protocol Amendment

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 50

Answer

21 CFR Part 312

Answer

45 CFR Part 46

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

15 calendar days

Answer

30 calendar days

Answer

24 hours

Question 5

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

Accepted Answer

Genuine uncertainty about which treatment is superior

Answer

Equal randomization of subjects

Answer

Equal compensation for all participants

Answer

Balanced placebo-to-treatment ratio

Question 6

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

Accepted Answer

Notify the sponsor and document the protocol deviation

Answer

Immediately terminate the site

Answer

Instruct the site to re-consent the subject

Answer

Report directly to the FDA without sponsor notification