2. Is a TMF always required?
Yes. The documentation from a trial of an investigational medicinal product must be filed in the TMF. This requirement is set down in both EU and UK legislation (2001/20/EC Article 15(5) and SI2004/1031 [as amended] 31A). The TMF forms the basis for an inspection to confirm compliance with regulatory requirements (Directive 2005/28/EC Chapter 4, Article 16). The TMF is normally composed of a sponsor TMF, held by the sponsor organisation (or to whom this function is delegated), and an investigator site TMF, held by the investigator. These files together are regarded as comprising the entire TMF for the trial and should be established at the beginning of the trial.
Version 1: 17th December 2012
