Trial Master File

Trial Master File (TMF) Trial Master File (TMF)
The Trial Master File (TMF) is one of the main files (in addition to the Investigator Site File, ISF) in which all essential clinical trial documents must be stored. ICH-GCP section 8 lists which essential documents must be included in the TMF, the ISF, or in both folders. The ISF is located in test centers while the TMF resides with the sponsor.

The TMF is compiled by the sponsor of the study. It is a “living” file to which documents (e.g. Protocol amendments, résumés of new investigators, current laboratory certificates, monitoring reports) are added over the course of the study; documents in the TMF (such as delegation and training logs) must be kept up to date. The TMF can exist either physically or electronically. The TMF must be archived by the sponsor before the required archival date after the clinical trial.

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