Good Clinical Practice Guide
Results 1 to 2 of 2

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

  1. #1
    Forum Member
    Join Date
    Dec 2021
    Posts
    2

    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
    Forum Member
    Join Date
    Nov 2011
    Posts
    170
    Really good sources are:- MHRA GCP Guide 2012; EMA final guidance on TMF; EMA draft guidance on CSV in CTs; EMA GCP IWG webpages and their Q & As; MHRA GCP Inspectors Blogs; etc.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.

Posting Permissions

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