The European Medicines Agency (EMA) has published on 12/04/2017 the draft version of new guideline “on good clinical practice compliance in relation to trial master files” (TMF). This document includes and updates the guidance issued previously in the EMA draft reflection paper on TMFs, includes additional guidance from the ICH E6 revision, and provides additional guidance from the EMA. It also provides additional guidance regarding the destruction of originals, and maintenance of multiple electronic systems. The guidline includes several areas that need to be challenged during the consultation process, such as the obligation to maintain provenance of emails conflicts with the statement that only the final email in an email chain need be retained.

The draft guideline can be downloaded here.