Creation and Maintenance of Trial Master File

The Regulations state that clinical trials will be conducted according to the principles of GCP as defined in SI 2004/1031 and 2006/1928.

Regulation 31A requires that a readily available TMF is kept, which contains the essential documents relating to that clinical trial. Whilst demonstrating compliance with the principles of GCP, the filing of essential documents in an orderly, timely manner also greatly assists the smooth running of the trial and any future audit or inspection.

With the large volume of documentation required for each trial a satisfactory filing system is necessary.

It is the responsibility of the Chief Investigator to establish a TMF for each clinical trial they initiate, by utilising the TMF template associated with this SOP (see Section 5.1). Chief Investigators conducting multi-centre trials will also establish an ISF and to do this they will utilise the ISF template associated with this SOP (see Section 5.2). For Chief Investigators conducting single centre trials, it is acceptable for all documents to be held in one single file which will act as both the TMF and ISF.

Chief Investigators for multi-centre trials will ensure a suitable ISF is in use at host sites. They should also consider providing ISFs to the Principal Investigators at each of the other site locations.

Where there is an external Sponsor, the Principal Investigator may be provided with an ISF for their site, with the TMF being held by the Sponsor. If the Sponsor does not provide an ISF, it is the responsibility of Principal Investigators to establish one for themselves.

SOP: Creation and Maintenance of Trial Master Files (300Kb)

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