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Joint Research Management Office

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 7 - Costing and contracting

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 21 - Sponsorship, management and oversight of international-only research: Regulated studies and interventional research

SOP 23 - Risk assessment

SOP 25 - Informed consent

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 28 - Monitoring

SOP 31 - Non-compliances

SOP 33 - The investigation and Resolution of Research Misconduct allegations

SOP 34a - Research training

SOP 37 - Reporting serious & non-serious breaches of GCP or the trial protocol

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 38d - Data Management

SOP 39 - Personal access for research ('Research Passport')

SOP 40 - Vendor assessment

SOP 42a - IMP management - Barts Health/ Queen Mary sponsored studies

SOP 42b - Pharmacy involvement in hosted studies

SOP 43 - Laboratories

SOP 45 - Essential documentation including TMF

SOP 46 - Site selection, initiation and activation

SOP 47 - Trial committees

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 22 - JRMO audits

SOP 24 - Quality Managment System

SOP 26c - Pharmacovigilance 

SOP 27 - JRMO Internal Filing Process

SOP 29 - Creating, maintaining and distributing JRMO SOPs

SOP 34b - JRMO staff training and induction

SOP 41 - JRMO oversight of CTG and study-specific SOPs

 
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