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 by emailing RGEA.SOP@admin.ox.ac.uk.
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.
Subscribe to the RGEA core SOPs mailing list to receive updates and information related to the University core SOPs. Please send an email to: rgeacoresop-subscribe@maillist.ox.ac.uk from the email address you wish to subscribe from. This is an automated email, so you will not need to include a message or subject. You will receive an automated email back asking you to confirm your subscription. Simply reply to that automated subscription email (message can be blank) to complete your subscription.
You can unsubscribe from the RGEA core SOPs mailing list at any time. Simply send an email (using the email address you subscribed with) to rgeacoresop-unsubscribe@maillist.ox.ac.uk or by clicking the unsubscribe link at the bottom of one of our mailing list emails.
The following are copies of the 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: Document Archiving
- 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 of Good Clinical Practice or the Trial Protocol
- 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
- Declaration of Helsinki
- General Data Protection Regulation (GDPR)
- Guidelines for Good Clinical Practice (GCP) PDF
- Human Tissue Act 2004
- Medical Devices Regulations
- Medicines for Human Use (Clinical Trials) Regulations 2004
- Medicines for Human Use (Clinical Trials) Regulations amendments 2006a, 2006b, 2008
- Mental Capacity Act 2005
- UK policy framework for health and social care research
- CESP registration, submission and training
- Clinical trials toolkit
- Equator network
- Guidance for researchers on writing lay summaries
- Health Research Authority - Research Ethics Service
- Health Research Authority - What approvals and decisions do I need?
- Integrated Research Application System (IRAS)
- IRAS Organisation information document guidance
- Specific guidance for IRAS form
- MHRA website
- NIHR CRN - Am I eligible for NIHR Clinical Research Network Portfolio?
- Oxford University Hospitals NHS Foundation Trust R&D department
- UK Clinical Research Collaboration