What is a Site File?
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.
What should it look like?
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.
What training do you provide?
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 every two months.
Please be aware that anyone who wishes to attend this training must possess a valid GCP certificate or relevant research training confirmation and should be delegated the responsibility of managing the site file.
When is this training on and how do I book?
Please view the calendar on our Training and Development page 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