Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Regulatory Guidelines and Compliance Flashcards

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  1. Under ICH E6(R2), which party is primarily responsible for implementing and maintaining a quality management system for clinical trials?

    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.

  2. What is the purpose of a Clinical Study Report (CSR) as defined by ICH E3?

    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.

  3. Which FDA regulation requires that electronic records and electronic signatures used in regulated activities be trustworthy, reliable, and equivalent to paper records?

    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.

  4. An investigator delegates a task to an unqualified study coordinator without documenting the delegation. Which GCP principle is violated?

    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).

  5. Under 21 CFR Part 50, which population requires additional safeguards when obtaining informed consent?

    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.

  6. A sponsor transfers all monitoring responsibilities to a CRO. According to ICH E6(R2), what responsibility does the sponsor retain?

    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.

  7. Which of the following best describes a 'prospective' IRB review?

    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.