Standard Operating Procedures (SOPs)
The JRMO operates in accordance with detailed Standard Operating Procedures (SOPs).
These SOPs and their associated documents can also be used as models by those engaged in research, in which case local sign-off would normally be required.
Each SOP has been authorised and a master copy is kept in the JMRO. All electronic copies of research and development SOPs are ‘uncontrolled’.
Updates to SOPs are announced in our regular Research News Bulletin.
- To search for a particular SOP either scroll down the list below, separated into Researcher SOPs and JRMO staff SOPS, or use the numerical list at the left of this page.
- Alternatively, you can insert a keyword or number into the SEARCH box at the top right of this and all JRMO website pages (just left of the Barts Health logo).
If you have any questions about our SOPs please contact the JRMO’s GCP Team: research.governance@qmul.ac.uk
Researcher SOPs
SOP 1 - Research Project application
SOP 7a - Contracting for MHRA Regulated Studies
SOP 7b - Contracting for Interventional and Research Studies
SOP 8 - Site agreements for clinical trials
SOP 9 - Sponsorship of clinical investigation and other MHRA-Regulated medical device studies
SOP 10 - Confirmation of capacity and capability
SOP 11a - Barts Health/Queen Mary Sponsorship of MHRA-regulated studies
SOP 12a - Barts Health/ Queen Mary Sponsorship of interventional studies (Researchers)
SOP 13a - Barts Health/ Queen Mary Sponsorship of research studies (Researchers)
SOP 14 - Review of research including peer review and departmental authorisation
SOP 15 - Queen Mary REC application and approval procedure
SOP 16 - Data protection for research
SOP 16b - External Access to Patient Electronic Health Records
SOP 17b - Amendments for hosted studies
SOP 17c - Amendments for sponsored studies
SOP 18a - Study closure for sponsored MHRA-regulated studies
SOP 18b - Study closure for sponsored interventional and research studies and all hosted studies
SOP 19 - Annual Progress Reports
SOP 20 - Archiving for research projects
SOP 26a - Pharmacovigilance reporting for CTIMPs
SOP 26b - Safety reporting for sponsored non-CTIMPs
SOP 26d - Site level Pharmacovigilance for Clinical Investigations of Medical Devices
SOP 31 - Non-Compliance and reporting of Serious Breaches
SOP 33 - The investigation and Resolution of Research Misconduct allegations
SOP 38a - Use of computerised equipment in research projects
SOP 38b - Trial data management systems
SOP 38c - Computer System Validation for Interventional and Research studies
SOP 39 - Personal access for research ('Research Passport')SOP 42a - IMP management - Barts Health/ Queen Mary sponsored studies
SOP 42b - Pharmacy involvement in hosted studies
SOP 45 - Essential documentation including TMF
SOP 46 - Site selection, initiation and activation
JRMO staff SOPs
SOP 12b - Barts Health/ Queen Mary Sponsorship of interventional studies (JRMO)
SOP 13b - Barts Health/ Queen Mary Sponsorship of research studies (JRMO)
SOP 17a - Amendments for sponsored studies
SOP 24 - Quality Managment System
SOP 27 - JRMO Internal Filing Process
SOP 29 - Creating, maintaining and distributing JRMO SOPs
