menu

Joint Research Management Office

Performing research menu

Medical SOPs

The JRMO operates in accordance with detailed Standard Operating Procedures (SOPs).

The SOPs listed below specifically relate to research studies sponsored by Queen Mary University and/or Barts Health. These SOPs can also be used as models by those engaged in research, in which case local sign-off would normally be required.

SOPs that refer to Clinical Trials of Investigational Medicinal Products (CTIMPs) should also be considered a model of “Best Practice” for non-CTIMP studies.

Each SOP has been authorised and a master copy is kept in the JMRO office. As stated in SOP 36, all electronic copies of research and development SOPs are ‘uncontrolled’. Any updates will be announced in the research news bulletin.

To search for SOPs relating to a particular topic please use the ‘Search’ box, above right (next to the Barts Health logo).

For SOPs relating to externally sponsored studies, refer to the section “Hosted Study SOPs”.

SPONSORED STUDY SOPs

SOP 11a - Barts Health/ QMUL sponsorship process for researchers [PDF 468KB]

SOP 12a - Sponsorship of interventional studies: the process for researchers

SOP13a - Sponsorship of research studies: the process for researchers

SOP 14 - Review of Research v4.0 [PDF 440KB]

SOP 17c - Amendments for sponsored studies - process for researchers [PDF 622KB]

SOP 18a - Project closure (Sponsored research) v4 [PDF 4,074KB]

SOP 20 - Archiving for research projects [PDF 155KB]

SOP 26b - Pharmacovigilance and safety reporting for sponsored non-CTIMPs [PDF 92KB]

SOP 28 - Monitoring [PDF 660KB]

SOP 37 - Reporting serious breaches [PDF 116KB]

SOP 38b - Trial data management systems [PDF 656KB]

SOP 40 - Vendor assessment [PDF 300KB]

SOP 42a IMP management - sponsored CTIMPs [PDF 506KB]

SOP 45 - External documentation including Trial Master Files and files for all external sites and facilities [PDF 252KB]

SOP 46 - site selection, initiation and activation [PDF 602KB]

SOP 47 - Trial committees [PDF 454KB]

HOSTED STUDY SOPs

SOP 16 - Data protection for research projects [PDF 145KB]

SOP 17b - Amendments for hosted studies - process for researchers

SOP 18b - Project closure guidance for research staff of hosted studies [PDF 387KB]

SOP 20 - Archiving for research projects [PDF 155KB]

SOP 26a - Pharmacovigilance reporting for CTIMPs [PDF 485KB]

SOP 42b - Pharmacy involvement in hosted studies [PDF 125KB]

GENERAL RESEARCH PROCEDURE SOPs

SOP 16 - Data protection for research projects

SOP 27 - Reporting incidents relating to research [PDF 144KB]

SOP 29 - Document control [PDF 171KB]

SOP 31 - Non-compliances v3 [PDF 70KB]

SOP 25 - Informed consent V6.0 [PDF 495KB]

SOP 32 - Freedom of Information v5.0 [PDF 296KB]

SOP 33 - The investigation and resolution of research misconduct allegations [PDF 2,985KB]

SOP 34a - Researcher training v7 [PDF 254KB]

SOP 38a - Use of computerised equipment, software and systems in clinical research [PDF 256KB]

SOP 39 - Personal access for research V6 [PDF 374KB]

If you have any questions about our SOPs please contact the JRMO’s GCP Team: research.governance@qmul.ac.uk 

Return to top