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

The principle of beneficence obligates researchers to maximize possible benefits and minimize possible harms when conducting research with human subjects.

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

The CRA must document the deviation and work with the site to re-consent affected subjects using the current approved form, while reporting to the sponsor per the monitoring plan.

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

Audits under ICH E6(R2) are systematic, independent examinations of trial-related activities and documents to evaluate whether the trial is conducted per the protocol, SOPs, GCP, and regulations.

Question 4

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

Accepted Answer

Drug identity, purity, potency, and quality

Answer

A CoA documents that the investigational product meets specified quality attributes including identity, purity, potency, and other release specifications.

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 50 specifies that the information given to subjects must be in language understandable to the subject or their legally authorized representative.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Regulatory Compliance and ICH-GCP 2