Resources for clinical research governance

University core SOPs, safety reporting documents, and protocol and report templates

University core SOPs should be used for all clinical trials sponsored by the University, and clinical research where appropriate.

If you require more detail than appears in a relevant University core SOP, unit SOPs or work instructions may be developed, provided they are compliant with University core SOPs. An editable version of the core SOP is available on request.

Other templates can be adapted for use in any department conducting clinical research where there are no such templates in place. Content should be reviewed in conjunction with guidelines/procedures that are unique to each department and the text altered accordingly.

Text highlighted in yellow within documents is advisory and should be deleted when documents are finalised. If there is a footnote with details of the original author and the copyright logo of the University of Oxford, please retain them.

Please refer to this page for the latest approved version of each document and for new core SOPs.

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Please email RGEA.SOP@admin.ox.ac.uk to request a copy of the following University Core SOPs:

  • University Core SOP 1: Generation Issue and Control of SOPs
  • University Core SOP 2: Protocol development 
  • University Core SOP 3: Safety reporting for CTIMPs
  • University Core SOP 4: Training for clinical research
  • University Core SOP 5: Archiving documents
  • University Core SOP 6: Trial Master File
  • University Core SOP 7: Preparation of participant information sheets & informed consent forms
  • University Core SOP 8: Serious breach reporting
  • University Core SOP 9: Managing complaints arising from clinical research
  • University Core SOP 10: Urgent safety measures
  • University Core SOP 11: Registration, applications, amendments and reporting
  • University Core SOP 12: Monitoring
  • University Core SOP 13: Confidentiality and security of personal data
  • University Core SOP 14: Version control
  • University Core SOP 15: Data management
  • University Core SOP 16: Contracts for clinical research studies

Contacts

RGEA TEAM  

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