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Thread: MHRA produced FAQs for Risk Adaptive Approach

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    MHRA produced FAQs for Risk Adaptive Approach

    Where can I find further information on this subject?

    The following publication is available on the MHRA website:
    MRC/DH/MHRA Joint Project: Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products

    Information on the MHRA's Notification Scheme is available here: Submitting a notification for a trial

    The following FAQs are presented below:
    1. What is the scheme that the MHRA have implemented?
    2. Does a risk assessment have to be completed for all trials?
    3. Should there be a documented process for the risk assessment?
    4. Is it expected that the trial is given an overall risk rating?
    5. When should the risk assessment be undertaken?
    6. Who should conduct the risk assessment?
    7. Should the risk assessment be documented?
    8. What should happen to the risk assessment once it is completed and documented?
    9. Does the MHRA recommend a specific methodology to be used for quantifying risk?
    10. Can the risk assessment be amended?
    11. Will MHRA GCP Inspectors want to see the risk assessment at a GCP inspection?
    12. Is the safety monitoring plan (suggested to be submitted as part of the CTA) part of the risk assessment?
    13. Should the risk assessment consider investigator site staff experience and training in clinical trials/GCP etc.?
    14. Who should review the risk assessment?
    15. Is it necessary to submit the risk assessment to the MHRA and the REC?
    16. The guidance suggests that the CI/sponsor?s assessment of the IMP risk category is included in the CTA application and gives an example of how this could be presented. Would the GCP Inspectorate consider this level of detail to be sufficient as an assessment of the IMP risk category (within a wider risk assessment of the trial) for the TMF?
    17. Can the risk assessment be discussed with the MHRA prior to submission of the CTA?
    18. Won?t the risk assessment process increase the paperwork required for a clinical trial?
    19. Does the risk assessment need to be global or country specific?
    20. Are there examples of risk assessments?
    Last edited by MHRA Super Moderator; 29th Mar 2012 at 04:13 PM.

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