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Get the free Post-IRB Approval Reviews - Research at Penn State

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Policy Title:QA/QI Review of IRB Files and OperationsEffective Date:October 8, 2015Policy Number:MHC_RP0304Review Date:August 20, 2020Section:Research IntegrityRevised Oversight January 20, 2023,
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How to fill out post-irb approval reviews

01
Start by gathering all necessary documents related to the IRB approval and the study.
02
Review the initial IRB approval requirements and compare them to the study results.
03
Evaluate any changes or deviations that were made during the course of the study.
04
Document any adverse events or unexpected outcomes that occurred during the study.
05
Clearly outline any modifications or additions that are needed to maintain compliance with the IRB approval.
06
Submit the post-IRB approval reviews in a timely manner to the appropriate regulatory body.

Who needs post-irb approval reviews?

01
Researchers conducting studies that were approved by an Institutional Review Board (IRB) need to complete post-IRB approval reviews.
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Post-IRB approval reviews are evaluations conducted after a study has been approved by an Institutional Review Board (IRB) to ensure ongoing compliance with regulations and ethical standards.
Researchers conducting studies approved by an IRB are required to file post-IRB approval reviews.
Post-IRB approval reviews can be filled out by providing details on study progress, protocol deviations, adverse events, and any other relevant information.
The purpose of post-IRB approval reviews is to monitor and oversee the conduct of research studies to ensure the protection of human subjects and compliance with regulations.
Information such as study progress, protocol deviations, adverse events, and any changes to the research protocol must be reported on post-IRB approval reviews.
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