CTA Regulatory Guidelines and Compliance 3 — Questions and Answers
Question 1: Under ICH E6(R2), which party is primarily responsible for implementing and maintaining a quality management system for clinical trials?
- The investigator
- The IRB/IEC
- The sponsor (Correct answer)
- The contract research organization (CRO)
Correct answer: The sponsor
ICH E6(R2) places primary responsibility on the sponsor to implement and maintain a quality management system proportionate to the risks inherent in the trial.
Question 2: What is the purpose of a Clinical Study Report (CSR) as defined by ICH E3?
- To summarize enrollment metrics for site staff
- To provide an integrated report of the trial's methods, results, and conclusions (Correct answer)
- To document investigator credentials and site qualifications
- To report adverse events to regulatory authorities during the trial
Correct answer: To provide an integrated report of the trial's methods, results, and conclusions
ICH E3 defines the CSR as a comprehensive document integrating study methods, clinical results, and statistical analyses to support regulatory submissions.
Question 3: Which FDA regulation requires that electronic records and electronic signatures used in regulated activities be trustworthy, reliable, and equivalent to paper records?
- 21 CFR Part 50
- 21 CFR Part 56
- 21 CFR Part 11 (Correct answer)
- 21 CFR Part 312
Correct answer: 21 CFR Part 11
21 CFR Part 11 establishes criteria under which FDA considers electronic records and electronic signatures to be trustworthy and equivalent to traditional paper-based records.
Question 4: An investigator delegates a task to an unqualified study coordinator without documenting the delegation. Which GCP principle is violated?
- Informed consent
- Delegation of authority (Correct answer)
- Randomization integrity
- Data blinding
Correct answer: Delegation of authority
Delegation of authority requires that all delegated tasks be assigned only to qualified personnel and documented on a delegation log, per ICH E6(R2).
Question 5: Under 21 CFR Part 50, which population requires additional safeguards when obtaining informed consent?
- Elderly participants over 65
- Vulnerable subjects such as children and prisoners (Correct answer)
- Participants with prior trial experience
- Non-English speaking participants only
Correct answer: Vulnerable subjects such as children and prisoners
21 CFR Part 50 Subpart D requires additional IRB-approved protections for vulnerable populations including children, prisoners, and economically or educationally disadvantaged persons.
Question 6: A sponsor transfers all monitoring responsibilities to a CRO. According to ICH E6(R2), what responsibility does the sponsor retain?
- No responsibilities — CRO assumes full liability
- Oversight of the CRO's performance of those responsibilities (Correct answer)
- Only financial responsibility for the trial
- Responsibility for IRB approvals only
Correct answer: Oversight of the CRO's performance of those responsibilities
Even when a sponsor transfers trial-related duties to a CRO, ICH E6(R2) requires the sponsor to retain ultimate responsibility and oversight of the CRO.
Question 7: Which of the following best describes a 'prospective' IRB review?
- Review conducted after trial completion to assess outcomes
- Review and approval obtained before the research begins (Correct answer)
- Annual continuing review of an ongoing trial
- Review triggered by a serious adverse event report
Correct answer: Review and approval obtained before the research begins
Prospective IRB review means that ethical review and approval must be obtained before enrolling any subjects or initiating trial-related procedures.
CTA Regulatory Guidelines and Compliance 3
Under ICH E6(R2), which party is primarily responsible for implementing and maintaining a quality management system for clinical trials?