EMA: Draft guideline on good -clinical -practice compliance in relation to trial master file (paper

The guideline on Trial Master File (TMF) aims to describe the requirements for TMF as covered in the new Clinical Trials Regulation (EU) No 536/2014 and ICH-GCP E6 and to assist organisations in maintaining a TMF that facilitates trial management, good-clinical-practice (GCP) compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitisation and consecutive destruction of paper documentation.

Posted on the EMA website on 12 April 2017

Consultation Period closes: 11th July 2017

EMA web link:

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