|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|
|Status||draft: consultation open|
|Consultation start date||2017-04-12|
|Consultation end date||2017-07-11|
|Email address for email@example.com|
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.