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trial master file - TMF

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Begriff Definition
trial master file - TMF
A trial master file (TMF) is the collection of essential documents that is used by sponsors, CROs and investigators/institutions for the management of the trial and by 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.
Unlike the ISF, the TMF remains by the sponsor.