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Thread: Clinical trials Regulation EU No 536/2014 - record retention responsibilities of CROs

  1. #1
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    Clinical trials Regulation EU No 536/2014 - record retention responsibilities of CROs

    Regarding this directive - as a CRO - what would be the responsibility for retention of trial data and supporting information beyond study lock?

    What data to retain?
    How long for?
    What format must the data be in? (bearing in mind technology-ageing issues of EDC systems that may be decommissioned within the retention period)

  2. #2
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    Really good sources are:- MHRA GCP Guide 2012; EMA final guidance on TMF; EMA draft guidance on CSV in CTs; EMA GCP IWG webpages and their Q & As; MHRA GCP Inspectors Blogs; etc. And of course all the EU & UK legislation.

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