CCRA Regulatory Compliance and ICH-GCP 2 — Questions and Answers
Question 1: Which Belmont Report principle requires that the benefits of research be maximized and harms minimized?
- Respect for persons
- Beneficence (Correct answer)
- Justice
- Autonomy
Correct answer: Beneficence
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?
- Halt all trial procedures at the site
- Document the finding and require re-consent using the current IRB-approved form (Correct answer)
- Terminate the investigator immediately
- Submit a serious breach report to the IRB without sponsor involvement
Correct answer: Document the finding and require re-consent using the current IRB-approved form
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:
- Conducted by the CRA during routine site visits
- Systematic independent evaluations to assess trial conduct (Correct answer)
- Performed only at the FDA's request
- Focused solely on financial compliance
Correct answer: Systematic independent evaluations to assess trial conduct
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:
- Subject eligibility criteria
- Drug identity, purity, potency, and quality (Correct answer)
- IRB approval dates
- Site staff qualifications
Correct answer: Drug identity, purity, potency, and quality
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?
- 21 CFR Part 56
- 21 CFR Part 50 (Correct answer)
- 45 CFR Part 46
- ICH E6(R2) Section 4.8
Correct answer: 21 CFR Part 50
21 CFR Part 50 specifies that the information given to subjects must be in language understandable to the subject or their legally authorized representative.
Question 6: A 'Competent Authority' in the context of EU clinical trial regulations refers to:
- The IRB or Ethics Committee
- A national regulatory body such as the MHRA or BfArM (Correct answer)
- The sponsor's medical monitor
- The CRO project manager
Correct answer: A national regulatory body such as the MHRA or BfArM
A Competent Authority is the national regulatory agency responsible for authorizing clinical trials in a given EU member state, such as the MHRA in the UK or BfArM in Germany.
CCRA Regulatory Compliance and ICH-GCP 2
Which Belmont Report principle requires that the benefits of research be maximized and harms minimized?