The draft E6(R3), that is revision 3, of the Good Clinical Practice guideline was released as draft for Consultation on 19 May by the ICH Assembly after completion by the Expert Working Group. Expect countries globally to release it for comment also - but that will take time. Those involved in any aspect of clinical trials should assess the revision to the GCPs to assess what has changed, but not act yet to change their practices as the final guidance will surely contain some differences. The volume of comments will be high given the topic and content; which runs to 73 pages with Appendices.
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