Site file

In order to comply with Good Clinical Practice and the Medicines for Human Use (Clinical Trial) Regulations as amended, all essential documents relating to a study must be retained in an investigator site file (ISF).  More than one file may be used but there must be clear sign-posts within the files that explain the filing system used and to allow documents to be traced.

Investigator site file template documents

Please refer to the R&D information sheet for guidance on establishing a suitable investigator site file (ISF).

The following template documents have been produced to assist with building a site file:

• ISF contents page: CTIMPs
• ISF contents page: non-CTIMPs
• ISF contents page: medical device studies
• Study information/contact page
• Subject screening and recruitment log
• Study specific document log
• Staff signature and delegation log
• Amendment/version control log
• Record of retained body fluids/tissue samples
• Drug accountability log
• Staff training log
• File note template

The R&D department encourages researchers to use these template documents and amend them (insert or delete columns/rows, change headers etc) to suit the needs of the specific study. However, it is acceptable to use a different format provided it meets the required standards.