Draft guideline on good -clinical -practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials

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Download document Draft guideline on good -clinical -practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials
Reference number EMA/15975/2016
Status draft: consultation open
First published 2017-04-12
Last updated 2017-04-12
Consultation start date 2017-04-12
Consultation end date 2017-07-11
Email address for submissions gcp@ema.europa.eu

Summary

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.