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Joint Research Management Office

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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 574KB]

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

SOP13a - Sponsorship of research studies: process for researchers

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

SOP 17c - Amendments for sponsored studies - process for researchers [PDF 514KB]

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

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

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

Associated document 1: AE flow chart (under review June 2016)

Associated document 2: SAE form [DOC 165KB] 

Associated document 3: DSUR template [DOC 183KB]

Associated document 4: DSUR MHRA cover letter template [DOC 35KB]

Associated document 5: BH / QMUL pregnancy reporting / follow-up form [DOC 107KB] 

SOP 26b - Safety reporting for non-CTIMPs [PDF 272KB]

Associated document 1: flow chart [PDF 33KB]

Associated document 2: SAE form [DOC 100KB]

SOP 28 - Monitoring [PDF 1,371KB]

Associated document 1: Monitoring plan template [DOC 168KB]

Monitoring forms:

Concise close out visit forms:

SOP 37 - Reporting serious breaches [PDF 116KB]

Associated document 1: notification of serious breaches, CTIMP [DOC 231KB]

Associated document 2: notification of serious breaches, non-CTIMP [DOC 45KB]

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

Associated document 1: CRF design guidance [DOC 75KB]

Associated document 2: good documentation practice [DOC 26KB] 

Associated document 3: user acceptance testing [DOC 20KB]

Templates 1: data management plan [DOC 28KB]

Template 2: Database change control form [DOC 36KB] 

Template 3: Sign off form [DOC 14KB]

Template 4: requirements and specifications [DOC 203KB]

SOP 40 - Vendor assessment [PDF 300KB]

Associated document 1: Vendor GCP compliance sample questions [PDF 16KB]

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

Associated document 1: IMP management plan template [DOC 93KB]

Associated document 2: IMP manual template [DOC 136KB]

Associated document 3: prescription template [PDF 462KB]

Associated document 4: accountability log template [PDF 1,167KB] 

SOP 45 - essential documentation and Trial Master file [PDF 279KB]

Associated document 1: TMF checklist template [DOC 118KB]

Associated document 2: TMF site sections checklist template [DOC 69KB]

Associated document 3: ISF checklist template [DOC 84KB]

Associated document 4: pharmacy site file checklist template [DOC 75KB]

Template 1: enrolement log [DOC 105KB]

Template 2: site delegation log [DOC 87KB]

Template 3: co-ordinating team delegation log [DOC 37KB]

Template 4: protocol version control log [DOC 135KB]

Template 5: PICS, ICF and GP letter version control log [DOC 147KB]

Template 6: amendment log [DOC 42KB]

Template 7: file note [DOC 169KB]

Template 8: file note log [DOC 34KB]

Template 9: trial specific training log [DOC 63KB]

Template 10: deviation log [DOC 63KB]

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

Associated document 1: Feasibility assessment guidance [PDF 369KB]

Associated document 2: JRMO site activation checklist template [DOC 36KB]

Associated document 3: JRMO SIV presentation [DOC 704KB]

Associated document 4: SIV report template [DOC 166KB]

SOP 47 - Trial committees [PDF 454KB]

Associated document 1: Sample charter [DOC 85KB]

Associated document 2: Example charter [DOC 95KB]

Associated document 3: Competing interests form [DOC 75KB]

Associated document 4: NIHR guidance [PDF 199KB]

HOSTED STUDY SOPs

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

Associated document: Research data protection checklist [PDF 22KB] 

SOP 17b - Amendments for hosted studies - process for researchers (SOP suspended, June 2016. If you have a query please contact research.amendments@barthhealth.nhs.uk)

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

Associated document 1: JRMO end of study notification form [DOC 53KB]

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

Associated document: Archiving charges [PDF 26KB]

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

Associated document 1: AE flow chart (under review June 2016)

Associated document 2: SAE form [DOC 165KB] 

Associated document 3: DSUR template [DOC 183KB]

Associated document 4: DSUR MHRA cover letter template [DOC 35KB]

Associated document 5: BH/QMUL pregnancy reporting /follow-up form [DOC 107KB] 

SOP 26b - Safety reporting for non-CTIMPs [PDF 272KB]

Associated document 1: flowchart [PDF 33KB]

Associated document 2: SAE form [DOC 100KB]

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

GENERAL RESEARCH PROCEDURE SOPs

SOP 16 - Data protection for research projects

Associated document 1: Research data protection checklist 

Associated document 2: Template delegation log [DOC 82KB]

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

SOP 29 - Document control [PDF 171KB]

SOP 31 - Non-conformances [PDF 149KB]

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

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

SOP 34a - Research training [PDF 242KB]

SOP 38a - Use of computerized equipment in research projects [PDF 445KB]

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.amendments@bartshealth.nhs.uk 

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