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Research Governance and Ethics Review in Kenya

10 Questions

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Research Governance and Ethics Review in Kenya

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@FeasibleTortoise

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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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