ICH Releases Draft GCP Addendum for Consultation

An integrated addendum to ICH E6(R1) Guideline for Good Clinical Practice has been released for public consultation (see LINK  for download). The addendum includes a small number of minor clarifications in section 8 of the guideline but no substantial changes specifically in this section. However, other areas of the addendum have an impact on the trial master file and records management processes.

The consultation process is open until 31 January 2016.

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
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