Good Clinical Practice Guide
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Thread: Sample Auditing Tools for Investigator Sites

  1. #1

    Question Sample Auditing Tools for Investigator Sites

    I appreciate that it is the responsibility of the investigator site to produce and maintain a comprehensive and effective QMS system, including maintaining it's own high quality audits.... Which is fine..

    But, I don't appear to have ever seen universal tools (outside of legislation and gcp) that ensure that SOP's and audits are effectively been maintained to the same standard. This includes internal audits of clinical trials ensuring that they are inspection ready.

    Perhaps that's just asking for too much common sense, or perhaps it's not feasible?

    I am particularly interested in good high quality audit tools though.

    Does anyone have any recomendations?

    Many thanks

  2. #2
    Forum Member
    Join Date
    Nov 2011
    I think you are right, I have not seen anything exactly like what you describe.
    However there are a lot of sources for helpful information.
    The MHRA GCP Guide 2012 has lots of information including on audits and QMS.
    Obviously the HRA and NHS R & D sites with toolkits.
    Its a great idea to join the Research Quality Association ( as it is an association for people like you. They have got lots of resources including virtual conferences; regional meetings; discussion forums; webinars etc. Well worth a look.

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