CCRA Regulatory Compliance and ICH-GCP 2

Question 1

Which Belmont Report principle requires that the benefits of research be maximized and harms minimized?

Accepted Answer

Beneficence

Answer

Respect for persons

Answer

Justice

Answer

Autonomy

Question 2

A CRA discovers that a site has been using an expired version of the informed consent form. What is the MOST immediate action?

Accepted Answer

Document the finding and require re-consent using the current IRB-approved form

Answer

Halt all trial procedures at the site

Answer

Terminate the investigator immediately

Answer

Submit a serious breach report to the IRB without sponsor involvement

Question 3

Under ICH-GCP E6(R2), the sponsor's audit differs from monitoring in that audits are:

Accepted Answer

Systematic independent evaluations to assess trial conduct

Answer

Conducted by the CRA during routine site visits

Answer

Performed only at the FDA's request

Answer

Focused solely on financial compliance

Question 4

A 'Certificate of Analysis' (CoA) for investigational product is used primarily to verify:

Accepted Answer

Drug identity, purity, potency, and quality

Answer

Subject eligibility criteria

Answer

IRB approval dates

Answer

Site staff qualifications

Question 5

Which regulation requires informed consent to be obtained in a language understandable to the subject?

Accepted Answer

21 CFR Part 50

Answer

21 CFR Part 56

Answer

45 CFR Part 46

Answer

ICH E6(R2) Section 4.8

Question 6

A 'Competent Authority' in the context of EU clinical trial regulations refers to:

Accepted Answer

A national regulatory body such as the MHRA or BfArM

Answer

The IRB or Ethics Committee

Answer

The sponsor's medical monitor

Answer

The CRO project manager