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Thread: Who requires GCP training?

  1. #1

    Who requires GCP training?

    Is there any information which specifies exactly who requires GCP training when taking part in research?

    Many Thanks

  2. #2
    Dear Laura

    A new Frequently Asked Question (FAQ) on GCP training has been posted today by the MHRA. Click here for details.

    Kind regards,
    MHRA Moderator

  3. #3
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    Dear MHRA moderator,
    As per FAQ on GCP training, it states duration of refreshing training every 2 years is not appropriate as there could be some changes in regulations. Please can you let us know how can we updated that something has been changed in the regulation. Is there any system available to communicate this issue.

  4. #4
    MHRA moderator: You can subscribe to our email alert service (http://www.mhra.gov.uk/Stayconnected...vice/index.htm). There is usally a consultation period before any changes to regulations are made and also there is a period between the regulations are enacted and enforced. New regulations are well publicised in advance of their enforcement and the news are channelled through symposium, consultative committee meeting, inspections and our website.

  5. #5
    Quote Originally Posted by laura.upton View Post
    Is there any information which specifies exactly who requires GCP training when taking part in research?

    Many Thanks
    I think it's a requirement for every one.
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  6. #6
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    "Everyone" is not a very helpful definition.
    Best to look at the MHRA Super Moderators guidance three sections below. The FAQs and the MHRA GCP Guide (2012) give some advice:- "Training needs may range from a detailed knowledge of GCP principles and associated UK Regulations and European guidance to an awareness of particular GCP principles, and training can be tailored accordingly. If an activity is part of a personís normal clinical role and all other protocol activities are undertaken by a member of the research team, then no GCP training may be required; however this should be reviewed as part of the risk assessment for a trial. The MHRA strongly recommends training in relevant aspects of GCP for anyone involved in conducting CTIMPs, even if the activities are part of an individualís routine job (for example, tailored training in aspects such as documenting activities in source notes and recording adverse events). It is recommended that assessments of the scope or level of GCP training required by particular individuals or roles are documented."

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