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Site file maintenance

All studies must have a site file to promote successful management of research and aid in document storage. We can offer you or one of your research team practical advice and assistance in setting up your site file in preparation for the start of the study. A mutually convenient time can be arranged to do this on site. If you would be interested in this service please contact the Research Management Office on 0117 34 20233.

We also have some guidance sheets and templates which can be used to help you set up your site file - please refer to templates, guidance documents and SOPs.

  • Guidance on setting up a site file - IMP studies
  • Guidance on setting up a site file - Non-IMP studies
  • Template for site file - IMP studies
  • Template for site file - Non-IMP studies

The contents of a site file should reflect the 'essential documentation' which is required by ICH Good Clinical Practice.