Standard Operating Procedures
This section contains the College's approved Standard Operating Procedures (SOPs) for health-related research. Please note, all SOP are referenced with JRO/SOP/xxx. The SOPs are all in pdf format. The SOPs are generic, please adapt them to make study-specific procedures.
Topics include:
- Protocols
- Ethics and Consent
- ICHT
- NIHR Studies
- Safety Reporting
- Essential Documentation/Trial Master File
- Case Report Form Design
- Sponsorship and Indemnity
- Obtaining Approvals / Approval Bodies
- Monitoring and Auditing
- Trial Management
- Research Passports
- Research Misconduct
Please refer to this page often as the most up-to-date version of each SOP will appear on this page. If you have any questions, please contact a member of the Joint Research Office.
Please contact the JRO if you would like a template for documents such as Protocols, Information Sheets, or Consent forms, etc.
1. Protocols
Protocol Development
Protocol Amendments
2. Ethics and Consent
3. Imperial College Healthcare Trust
- Imperial College Healthcare Trust Approval JRO/SOP/031
- Imperial College Healthcare Trust Amendment Approval JRO/SOP/32
4. NIHR Studies
5. Safety Reporting
- Recording, Managing and Reporting Adverse Events in the UK JRO/SOP/001
- Development Safety Update Reporting for IMP Clinical Trials JRO/SOP/035
6. Essential documentation/trial master file
7. Case Report Form (CRF) Design
8. Sponsorship and Indemnity
9. Obtaining Approvals / Approval Bodies
Clinical Trials Authorisation
Gene Therapy Advisory Committee (GTAC) Application
Human Fertilisation and Embryology Authority
HFEA License Applications JRO/SOP/023
NIGB
Medical Devices
Xenotransplantation
10. Monitoring and Audit
11. Trial Management
- SOP Writing and Reviewing JRO/SOP/011
- Managing Research Participant Complaints JRO/SOP/013
- Notification of Serious Breaches of GCP or the trial protocol JRO/SOP/021
- Quality Control and Quality Assurance JRO/SOP/025
- IMP Management and Accountability JRO/SOP/026
