Good Clinical Practice Guide
Results 1 to 10 of 21

Thread: MHRA produced FAQs for Risk Adaptive Approach

Hybrid View

  1. #1

    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.

  2. #2
    1. What is the scheme that the MHRA have implemented?

    The MHRA have implemented a dual strategy for a risk-adapted approach for clinical trials in the UK.

    The first is a stratification approach into type A, B or C dependent upon the use of the investigational medicinal product (IMP) in relation to its marketing authorisation or an unlicensed IMP, i.e. the risks associated with the IMP. This would impact on the MHRA authorisation process, indicate potential changes to trial documentation requirements and inform the safety monitoring plan.

    The second is a bespoke approach. This is a trial specific risk assessment to identify specific vulnerabilities in the trial conduct that could impact on the trial results and the protection of trial subjects? safety, rights and well being. This risk assessment would document the mitigations for specific identified risks and any adaptations from ?traditional? GCP. These would then be developed such that there would be risk proportionate management and monitoring of the trial.

    For further details consult the MHRA website below:
    http://www.mhra.gov.uk/home/groups/l.../con111784.pdf
    Version 1: 01 March 2012

  3. #3
    2. Does a risk assessment have to be completed for all trials?

    It is recommended that a risk assessment is undertaken for all clinical trials. Identification of potential risks to trial subjects and to the reliability of the trial results on a trial basis and taking actions to mitigate those risks can only be beneficial for the quality of any clinical trial. In the UK Phase 1 Accreditation scheme, Phase 1 units are required to have a documented risk assessment process and to produce a risk assessment for all proposed trials for this reason. It is essential that trials that have a risk-adapted approach applied have a risk assessment undertaken.
    Version 1: 01 March 2012

  4. #4
    3. Should there be a documented process for the risk assessment?

    Where sponsors are conducting many trials, a documented process for how the risk assessment should be undertaken is advisable to ensure the consistency of the approach taken by the organisation. The risk assessment must be specific to the proposed trial and whilst the process may include templates or a guide on the areas to consider in the risk assessment, care should be taken to examine the potential risks of the proposed trial, which may present new areas that have not been considered in previous trials. This is why it is a bespoke approach.

    Version 1: 01 March 2012
    Last edited by MHRA Super Moderator; 15th Mar 2012 at 03:39 PM.

  5. #5
    4. Is it expected that the trial is given an overall risk rating?

    The MHRA scheme uses the Investigational Medicinal Product (IMP) marketing authorisation status to categorise into types A, B and C in relation to the authorisation process and potential documentation required for a trial. This categorisation is not equivalent to a risk rating, though it gives an indication that a trial of type C may involve more potential risks than one of type A. The real risk of the trial is obtained by an evaluation of the potential risks from conducting the trial, not just from the IMP marketing status ? this is why a full bespoke trial specific risk assessment is required. For example a trial may be assessed as type A based on the IMP status; however there may be other risks associated with the trial procedures and/or the use of a vulnerable population that would mean that it was not in fact a low risk trial. It is therefore recommended that a risk assessment process whereby an overall risk score for the trial is generated which leads to generic actions (e.g. a low score = no monitoring; high score = on site monitoring) is used with some caution. Whilst an overall risk score can give a useful indication of the trial?s risk, the aim of the risk-adapted approach is to identify specific vulnerabilities within the trial and take appropriate actions for these. Specific high risk areas within the trial could potentially be overlooked by assigning a risk category to the entire trial. Conversely, the risk assessment process can also identify areas where adaptations from ?traditional? GCP could be implemented, as no particular risk is identified, for example, no requirement to monitor storage conditions for the IMP.
    Version 1: 01 March 2012
    Last edited by MHRA Super Moderator; 15th Mar 2012 at 03:40 PM.

  6. #6
    5. When should the risk assessment be undertaken?

    The risk assessment should be done as early as possible. This allows the sponsor to identify whether the proposed research falls under the CT legislation, whether the sponsor wishes to proceed with sponsorship (possibly for other reasons than patient safety/GCP compliance ? e.g. financial) and also the potential type (A, B, C). The process could be defined such that the risk assessment is undertaken on the research proposal and then further refined once the protocol has been drafted, thus there could be several steps to the process with different individuals involved. An early risk assessment will also identify the study management requirements, which can assist in the planning and resourcing aspects of the trial (e.g. identification of trial monitoring requirements so that these can be budgeted for in any funding application).

    Version 1: 01 March 2012
    Last edited by MHRA Super Moderator; 15th Mar 2012 at 03:40 PM.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •