Site File Management

A ‘site file’ is a collection of documentation that allows the conduct of the trial, the integrity of the trial data and the compliance of the trial with Good Clinical Practice (GCP) to be evaluated.

The Trial Master File/Investigator Site File (TMF/ISF) must be structured in a way that allows the reconstruction of the trial from the documentation alone. The documentation contained within the TMF/ISF should be sufficient to adequately reconstruct the trial activities undertaken, along with the key decisions made concerning the trial.

The TMF/ISF must be in place prior to commencement of study recruitment.

The training provides a generic guide to creating and maintaining a site file during the lifecycle of that study.

This face-to-face training will be provided on a quarterly basis. Click here to download the presentation for Site File Training.

Please be aware that anyone who wishes to attend this training:

  • Must possess a valid GCP certificate
  • Should be delegated the responsibility of managing the site file

Please view the calendar of training sessions to see upcoming sessions and dates.

For further information and to BOOK a place on one of sessions, please contact RITraining@uhl-tr.nhs.uk