Research Governance and Ethics Review in Kenya
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Questions and Answers

What is the purpose of monitoring oversight in clinical trials?

  • To evaluate the significance of trial results.
  • To determine the post-trial access to investigational products.
  • To ensure compliance with regulatory requirements and ethical standards. (correct)
  • To conduct regular inspections of clinical trial sites and data.

    • What is a significant challenge faced in adhering to ICH GCP guidelines?

  • Facilitating global acceptance of clinical trial data.
  • Addressing resource constraints and evolving regulatory landscapes.
  • Determining the safety and efficacy of investigational products.
  • Balancing speed and thoroughness in the review process. (correct)

    • What is the role of pharmacovigilance in clinical trials?

  • To rigorously evaluate trial results to inform regulatory decisions. (correct)
  • To assess the validity and significance of trial results.
  • To ensure compliance with ethical standards.
  • To conduct regular audits at clinical trial sites.

    • How does adherence to ICH GCP guidelines impact clinical trial data credibility?

    <p>It ensures patient safety and data reliability.</p> Signup and view all the answers

    Why is it essential to evaluate trial results for safety and efficacy?

    <p>To determine whether the results meet pre-defined safety and efficacy criteria.</p> Signup and view all the answers

    Regular inspections, audits, and reviews of clinical trial sites are not part of monitoring activities.

    <p>False</p> Signup and view all the answers

    ICH GCP guidelines focus on weakening the credibility and acceptance of clinical trial data globally.

    <p>False</p> Signup and view all the answers

    Balancing speed and thoroughness in the review process is not a challenge faced in adhering to ICH GCP guidelines.

    <p>False</p> Signup and view all the answers

    Pharmacovigilance plays no role in informing regulatory decisions after trial evaluations.

    <p>False</p> Signup and view all the answers

    Ensuring regulatory compliance is not important for maintaining patient safety in clinical trials.

    <p>False</p> Signup and view all the answers

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