Summary, Critical Details, And FAQ For Your TMF Management

This overview summarizes and interprets the EMA’s “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic).” This guidance was finalized at the end of 2018 and became effective in June of 2019.

The guidance was developed to assist clinical trial stakeholders in their compliance with current regulatory requirements (Directive 2001/20/EC and Directive 2005/28/EC) and the ICH E6 Good Clinical Practice (GCP) Guideline, as related to their use and management of the Trial Master File. The guidance was developed considering applicable requirements related to the pending Clinical Trials Regulation EU No 536/2014 and will continue to be relevant once the regulation is in effect.