Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Site Management & Monitoring Flashcards

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  1. Which of the following scenarios requires an expedited safety report to the FDA under 21 CFR 312.32?

    Answer: An unexpected serious adverse event with a reasonable possibility of being related to the investigational product

    21 CFR 312.32 requires expedited IND safety reports for unexpected serious adverse drug reactions that are reasonably possibly related to the investigational product.

  2. A monitoring visit reveals that a site coordinator has been pre-signing blank informed consent forms for convenience. This practice is:

    Answer: A serious GCP violation because consent must be obtained through a proper interactive process before any study procedure

    Pre-signing consent forms bypasses the required interactive consent process and constitutes a serious GCP violation regardless of subsequent PI review.

  3. What does a CAPA (Corrective and Preventive Action) plan address in the context of site monitoring?

    Answer: Actions taken to correct identified deficiencies and prevent recurrence of protocol or GCP violations

    A CAPA addresses root causes of identified problems and establishes actions to prevent recurrence, a core component of clinical trial quality management.

  4. According to ICH E6(R2), the sponsor must implement a system to manage quality 'proportionate to the risk posed by the trial.' This is the foundation of which approach?

    Answer: Risk-based quality management (RBQM)

    ICH E6(R2) introduced the RBQM framework, which focuses oversight resources on risks that matter most for subject safety and data integrity.

  5. When reviewing the site's delegation log, the CRA notices tasks were performed by a staff member not listed on the log. What is the appropriate CRA action?

    Answer: Document the finding as a GCP deviation, notify the PI, and request an updated delegation log and training records

    All individuals performing delegated study tasks must be documented on the delegation log; performing tasks without authorization is a GCP deviation requiring documentation and corrective action.

  6. A clinical trial uses a blind assessment design. During a monitoring visit, the CRA notices the randomization code has been broken for one subject. What should the CRA document this as?

    Answer: An unplanned unblinding, which is a protocol deviation requiring documentation and sponsor notification

    Unplanned unblinding is a protocol deviation that must be documented, reported to the sponsor, and assessed for its impact on data integrity and subject safety.

  7. Which ICH guideline specifically governs Good Clinical Practice standards for the design, conduct, and monitoring of clinical trials?

    Answer: ICH E6(R2)

    ICH E6(R2) is the internationally recognized GCP guideline covering all aspects of clinical trial conduct, including monitoring, documentation, and quality standards.