A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the investigator, the sponsor, and the institution conducting the trials.

TMF in electronic format is called eTMF, which is more advantageous as it uses software and server technology to guide and assist in collecting, storing, and archival essential clinical study documents.

Contents of Trial Mater File: The ICH E6 guideline describes what essential documents to be present in the TMF. The structure varies according to the size of the clinical trials and many other factors.

TMF requirements under GCP include the list of essential documents grouped into 3 categories according to the stage of clinical trial where they will be generated

1. Those required before the clinical phase of the trial commences,
2. Those required during the clinical conduct of the trial, and
3.  Those required after completion or termination of the trial.

The minimum list of essential documents required while designing a TMF includes an Investigator brochure, Informed Consent, Study Protocol, Insurance statement, institutional review board composition, etc.

As per ICH E6 Trial, master files must be created at the start of the trial, both at the investigator/institution’s site and at the sponsor’s office. close-out of the trial carried out after the monitor has reviewed the investigator and sponsor files.