The HRA Regulations require a Trial Master File (TMF) to be kept for a clinical trial, and if you have additional sites a Investigator Site File (ISF) should be kept locally. The TMF should be set up as soon as you plan to submit the research for funding. The file should include all information relating to the study, an example of the TMF and ISF file structure can be found under the SOP pages.

It is essential that the file is updated throughout the life of the trial, and information should be stored in a coherent format to enable ease of access and so they are readily available for GCP monitoring, audits or inspections.