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Trial initiation

Trial Master File

The Trial Master File (TMF) is a central repository for all essential documents and records generated during a clinical trial and is a requirement of Good Clinical Practice guidelines.

A TMF is created at the beginning of the trial to source all trial approval documentation. It is maintained throughout the trial to include any trial-related documentation. It should be maintained in accordance with the protocol and GCP.

It is essential to keep your TMF current and in order so that no further explanation from the sponsor or investigator is required when audited.

Things to consider when creating your Trial Master File:

Set up the structure 

  • Ensure there is an easy index with locations of essential documentation.
  • Utlise a TMF checklist to help set up the structure of your file.
  • Consider a well-structured process to keep the TMF up-to-date.
  • Ensure well-structured procedures and processes are in place that promote collaborative exchange of study records.

Content

  • Consider the minimum essential documents to be collated in your TMF. Review ICH Good Clinical Practice guidelines for the minimum documentation.
  • Routinely keep the content up to date, especially if dealing with multiple sites.
  • Ensure staff are trained on regularly keeping the content up to date.

Storage and archiving 

  • When, where and how will the TMF be stored and ultimately archived.
  • Consider security and controlled access for hard copies and password-protecting electronic files.
Standard operating procedures Pilot processes and documentation
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Further reading

Learn more about this topic with our helpful articles.

The Clinical Trial Master File

External resources

A curated list of resources from trusted sources on the web.

What is a Trial Master File?
Trial Master File
Trial Master file checklist

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