Standard operating procedures
Standard operating procedures
All our research must comply with the relevant legislation and should follow best practice guidelines.
These standard operating procedures (SOPs) cover the key research project activities.
Each SOP has a summary explaining when it was last updated and whether it applies to any particular types of research. Not all of the procedures apply to every project.
If you have problems accessing any of the files, find any broken links or would like further information you can email [email protected].
- SOP 1 - Writing and Managements of SOPs (R&I Staff required to write SOPs)
- SOP 2 - Document control (All projects involving human participants)
Setup phase
- SOP 3 Protocol development (All interventional projects, and projects requiring NHS/SCREC approval)
- SOP 4 PIS Consent form development (All projects involving human participants)
- SOP 5 CRF Development (All projects requiring NHS/SCREC approval that collect patient data)
- SOP 6 Ethics and External Approvals (All projects)
- SOP 7 Study master file and Site file setup (All projects requiring NHS/SCREC approval)
- SOP 8 Sponsorship (All projects requiring NHS/SCREC approval)
- SOP 16 The prevent duty in research (All projects)
- SOP 17 Management of Incidental Findings identified by Magnetic Resonance Imaging (MRI).
Recruitment phase
- SOP 9 Site Set-up - Document currently in development
- SOP 10 Informed consent for research (All projects involving human participants)
- SOP 11 Protocol deviations violations and AE reporting (All interventional projects)
- SOP 12 Monitoring and audit (All projects involving human participants)
- SOP 13 Data Management - Document currently in development
Closedown phase
- SOP 14 Study Closure - Document currently in development
- SOP 15 Archiving - Document currently in development