EMA Guideline on the Trial Master File (TMF) released on 6.Dec.2018

Trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors.

The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the protocol, the trial’s safe conduct and the quality of the data obtained.

The EMA guideline (link) is intended to assist the sponsors and investigators in complying with the requirements of the current legislation (Directive 2001/20/EC and Directive 2005/28/EC), as well as ICH E6 Good Clinical Practice (GCP) Guideline, regarding the structure, content, management and archiving of the clinical trial master file (TMF).

The guidance also applies to the legal representatives and contract research organisation (CROs), which includes any third party such as vendors and service providers to the extent of their assumed sponsor trial-related duties and functions.

The ICH GCP guideline provides information in relation to essential documents to be collected during the conduct of a clinical trial. The risk-based approach to quality management also has an impact on the content of the TMF.

To ensure continued guidance once the Clinical Trials Regulation (EU) No. 536/2014 (‘Regulation’) comes into application, this guidance already prospectively considers the specific requirements of the Regulation with respect to the TMF.

This EMA guideline on the TMF will come into effect 6 months after publication.

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