A Trial Master File (TMF) is a set of important documents used to evaluate whether the clinical trials are conducted as per the Regulatory requirements and Good Clinical Practice (GCP) standards by the sponsors/investigators/CROs. It is a summary of how the trials are carried out and managed. The accuracy and integrity of the TMF depend majorly on the quality management system of the sponsor or the CRO. The content of the TMF should be clear enough to trace back the activities of the conducted trial to justify the outcomes.

TMF Authoring

A TMF is generally composed as a sponsor TMF and as well as an investigator TMF. Following are the prerequisites of authoring a compliant TMF:

  • At the beginning of any trial, a TMF (both sponsor and investigator) must be presented
  • A record of all the locations, departments, countries and systems must be maintained before starting a clinical trial
  • All the primary essential documents of the TMF must be maintained electronically or on paper or both
  • Documents of a TMF applicable to multiple trials need not be duplicated
  • A proper index is required for tracking documents of a TMF

TMF Key Aspects

1. Essential Documents

The documents which permit the evaluation of a conducted trial and provide the authenticity of the data are known as the essential documents. These documents help the sponsors to manage the trial and demonstrate its alignment with the GCP standards and Regulatory requirements.

2. Superseded Documents

The procedures of sponsor/CRO may require input and review from various functions during the trial. Therefore, documenting those procedures is necessary. The superseded documents help the sponsors to re-trace the trial and, hence, must be included in the TMF.

3. Correspondence

Correspondences which can help in reconstructing the trial must be a part of the TMF.

4. Contemporariness of A TMF

A TMF must maintain all the documents added to it in a chronological manner along with defined timelines. This is more important for TMFs which are highly complicated and have multiple parties involved.

A complaint TMF is the key for successful evaluation of a clinical trial. Hence, authoring it with precision is of high importance. Are you looking for assistance to author a compliant TMF? Reach out to Freyr at sales@freyrsolutions.com