Site documents

Site documents are grouped into separate collections for your convenience. If you would like a specific document but unable to find it below, please contact us.

  • Regulatory documents
  • Manuals and SOPs
  • Investigator site file - 00 Index
  • Investigator site file - 01 Contact list
  • Investigator site file - 02 Protocol
  • Investigator site file - 03 REC & HRA approval
  • Investigator site file - 04 Capability and capacity
  • Investigator site file - 05 Investigator personnel
  • Investigator site file - 06 Study documentation
  • Investigator site file - 07 Enrolment log
  • Investigator site file - 08 SOP
  • Investigator site file - 09 SAE reporting
  • Investigator site file - 10 Informed consent
  • Investigator site file - 11 Data
  • Investigator site file - 12 Monitoring audit
  • Investigator site file - 13 Laboratory
  • Investigator site file - 14 Study related supply
  • Investigator site file - 15 Financial and legal
  • Investigator site file - 16 Publications
  • Investigator site file - 17 Correspondence
  • Investigator site file - 18 Miscellaneous
  • Site initiation visit and amendments Training
  • CRFs and questionnaires
  • Notifications
  • eConsent

There is currently no document available in the collection: Investigator site file - 03 REC & HRA approval

There is currently no document available in the collection: Investigator site file - 04 Capability and capacity

There is currently no document available in the collection: Investigator site file - 06 Study documentation

There is currently no document available in the collection: Investigator site file - 10 Informed consent

There is currently no document available in the collection: Investigator site file - 12 Monitoring audit

There is currently no document available in the collection: Investigator site file - 13 Laboratory

There is currently no document available in the collection: Investigator site file - 14 Study related supply

There is currently no document available in the collection: Investigator site file - 16 Publications

There is currently no document available in the collection: Investigator site file - 17 Correspondence

There is currently no document available in the collection: Investigator site file - 18 Miscellaneous