A Trial Master File (TMF) is the collection of essential documents that is used by Sponsor, CROs, and Investigators/Institutions for the management of the trial and by data monitors, auditors and inspectors to review and verify whether the Sponsor and the Investigators/Institutions have conducted the trial in line with the applicable regulatory requirements and the principles and standards of GCP . A TMF will contain all the essential documents needed for the trial to be conducted. It will also hold the source documents, from which the trial can be audited and by which adherence to the principles of GCP can be demonstrated. The TMF includes an Investigator Site File (ISF), held by each investigator in the site.
