2. What are the requirements for the provision of TMFs for inspection?
As per Regulation 31A (1) – (4) and Directive 2005/28/EC Articles 16 & 17 the TMF is the basis for the inspection and should be complete and readily available.
You should ensure that you have identified ALL the trial documentation and its location that comprises the Trial Master File and determined how this will be made readily available to the inspectors. Remember that the TMF may consist of trial relevant documentation held in files of various departments, e.g. pharmacovigilance, data management, statistics, R&D etc.
Where the sponsor has subcontracted activities, perhaps the TMF management itself to a CRO, then the TMF and/or the files & documentation held by the sponsor as part of their oversight will need to be provided.
ALL the documentation that comprises the TMF (that is the documentation that allows the inspectors to evaluate the conduct of trial) must be made available for direct access by the inspectors, including any electronic documentation (for example email correspondence). In many inspections, findings have been given as the organisation has failed to comply with this requirement, even when this has been clearly set out prior to the inspection. Any equipment and software etc to access any electronic documentation will need to be provided by the organisation.
Prior to the inspection, the inspector(s) are happy to discuss how the TMF will be provided. This may be necessary where the organisation of the TMF is complex, for example, parts or all of it is held outside of UK.
Further information on TMFs can be found in Chapter 10 of the MHRA GCP Guide and in FAQs on this GCP Forum relating to the TMF and archiving.
Version 1: 21 December 2012
