GCP: EMA Draft Guideline relating to the Trial Master File

In April 2017 the European Medicines Agency (EMA) has released a 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. The draft has been adopted by the GCP Inspectors Working Group (GCP IWG). The public consultation period has started on April 12, the deadline for comments is July 11, 2017.
Into this draft guideline, which has been prepared as part of the work related to the implementation of the new Clinical Trial Regulation (EU) 536/2014, a revised version of the reflection paper on trial master file (TMF) has been incorporated, which also considers the comments collected during the public consultation (01 February – 30 April 2013).

A TMF is the collection of essential documents that facilitates the conduct and management of the clinical trial and allows that the integrity of the trial data and the compliance of the trial with GCP can be evaluated. The TMF is used by sponsors and investigators for the management of the trial and by auditors, monitors and inspectors to assess whether the sponsor and the investigator(s) have complied with the Clinical Trials Regulation (EU) No 536/2014 (referred to as the "Regulation"), the principles and guidelines of GCP and with other applicable regulatory requirements.

The EMA states that the guideline has been prepared to assist sponsors and investigators to comply with the requirements of the Regulation on clinical trials on medicinal products, concerning the trial master file (TMF). According to recital 52 of the Regulation "in order to be able to demonstrate compliance with the protocol and with this Regulation, a clinical trial master file, containing relevant documentation to allow effective supervision (monitoring by the sponsor and inspection by Member States), should be kept by the sponsor and by the investigator". Articles 57 and 58 of the Regulation make this mandatory. The same applies to the legal representatives and CROs or any other third party to the extent of their assumed trial related duties and functions. 

  • Article 57 states “the clinical trial master file shall at all times contain the essential documents relating to that clinical trial.” The requirement “at all times” means that the TMF should be updated, and completed in a timely manner.
  • Article 58 of the Regulation also requires that “any alteration of the content of the trial master file shall be traceable”.

The TMF should provide for document identification, version history, search, and retrieval, also, as stated in Articles 57 (and 58) “it shall be readily available, and directly accessible upon request, to the (competent authorities of the) Member States”. Additionally, the same requirements for access to the TMF should be in place for the monitors, auditors and ethics committees.  

The EMA says that this guideline aims to collate and explain the requirements for the TMF as covered in the Regulation and ICH E6 (Good Clinical Practice) to assist organizations in maintaining a TMF that facilitates trial management, GCP compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and consecutive destruction of paper documentation.

On the EMA website you can find the draft Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials open for consultation.

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