Good Clinical Practice Guide
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Thread: MHRA produced FAQs for Risk Adaptive Approach

  1. #21
    20. Are there examples of risk assessments?

    Yes. The MHRA GCP Inspectorate has set up a collaborative group to produce FAQs and produce example documentation relating to the risk adaptive approach. The risk assessments are not intended to be definitive templates or tools, but are provided as examples of what risk assessments may look like and organisations may use the examples to help develop their own risk assessment processes. The examples are not intended to be definitive approaches. They are not endorsed or recommended by the MHRA.

    The examples have been posted in the thread entitled "Examples of risk assessments".

    Examples will continue to be added as they are developed for other trials.


    Version 3: 05 March 2013
    Last edited by MHRA Super Moderator; 14th Nov 2014 at 11:02 AM. Reason: Example risk assessments moved to a separate thread.

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