Policies, Standard Operating Procedures and Templates

The documents hosted on this page are up-to-date and accurate. If you have any queries or can't find what you're looking for, please contact: researchgovernance@sgul.ac.uk

The Joint Research and Enterprise Services (JRES) have developed a suite of standard operating procedures (SOPs) and template documents for research sponsored by and/or conducted within St George’s, University of London and St George’s University Hospitals NHS Foundation Trust.

For any procedures, logs or templates not listed below, please contact the JRES directly via the research governance inbox.

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Policies and Guidance

JRESGOVPOL0001 Clinical Trial Transparency Policy V5.0_16.06.2025 (PDF)

Guidance on Databases for Research Projects V4.0_17.06.2025 (PDF)

JRESGOVPOL0002 Research Tissue Bank Policy V1.0_01.07.2025 (PDF)

SOPs

JRESGOVSOP0001 Preparation, Approval and Review of JRES SOPs V7.0_15.04.2021 (PDF)

JRESGOVSOP0003 Sponsorship for CTIMPs V10.0_17.01.2022 (PDF)

JRESGOVSOP0006 Reporting of AEs for CTIMPs V12.0_08.02.2022 (PDF)

JRESGOVSOP0008 Annual Safety Reporting and Progress Reporting V5.0_16.04.2021 (PDF)

JRESGOVSOP0009 Site Initiation Monitoring and Close-Out for CTIMPs V7.0_16.04.2021 (PDF)

JRESGOVSOP0011 Management of Amendments StG Sponsored V10.0_16.04.2021 (PDF)

JRESGOVSOP0012 Protocol and GCP Deviations V7.0_16.04.2021 (PDF)

JRESGOVSOP0015 End of Study Notification V6.0_20.04.2021 (PDF)

JRESGOVSOP0016 Archiving V6.0_16.04.2021 (PDF)

JRESGOVSOP0017 Confimation of Capacity and Capability V10.0_25.05.2021 (PDF)

JRESGOVSOP0019 Preparation and Maintenance of the TMF V7.0_20.04.2021 (PDF)

JRESGOVSOP0023 Training Requirements for Clinical Research V4.0_22.04.2021 (PDF)

JRESGOVSOP0024 Computerised Systems V3.0_22.04.2021 (PDF)

JRESGOVSOP0026 Handling Research Participant Complaints V4.0_22.04.2021 (PDF)

JRESGOVSOP0028 Applying for Sponsorship for Non-CTIMPs V6.0_23.05.2021 (PDF)

JRESGOVSOP0027 Informed Consent V4.0 (PDF)

JRESGOVSOP0031 Escalation Procedure V4.0_22.04.2021 (PDF)

JRESGOVSOP0032 Reporting of Serious Breaches V4.0_23.04.2021 (PDF)

JRESGOVSOP0033 Safety Reporting for Non CTIMPs V5.0_11.05.2021 (PDF)

JRESGOVSOP0034 Preparation Review and Management of CRF and VI SOPs V4.0_23.04.2021 (PDF)

JRESGOVSOP0035 Auditing V4.0_17.10.2023 (PDF)

JRESGOVSOP0036 Laboratory Procedures V3.0_23.04.2021 (PDF)

JRESGOVSOP0037 Equipment Maintenance V4.0_23.04.2021 (PDF)

JRESGOVSOP0038 Data Management V3.0_23.04.2021 (PDF)

JRESGOVSOP0039 Protocol Design V4.0_23.04.2021 (PDF)

JRESGOVSOP0042 Applying to the HRA under section 251 V4.0_26.04.2021 (PDF)

JRESGOVSOP0046 Transferring Sponsorship V3.0_26.04.2021 (PDF)

JRESGOVSOP0048 Management of Host Site Amendments V2.0_26.10.2021 (PDF)

JRESGOVSOP0049 Delegation of Sponsorship Duties V1.0_26.04.2021 (PDF)

JRESGOVSOP0050 Site Feasibility and Selection V1.0_26.04.2021 (PDF)

JRESGOVSOP0051 Trial Oversight Committees V1.0_26.04.2021 (PDF)

JRESGOVSOP0052 Preparing for an MHRA GCP Inspection V1.0_26.04.2021 (PDF)

JRESGOVSOP0053 Vendor Selection V1.0_26.04.2021 (PDF)

JRESGOVSOP0055 E-Consent for Clinical Research V1.0_25.05.2021 (PDF)

JRESGOVSOP0056 Sponsorship and Governance Processes for International Studies V2.0_12.10.2022 (PDF)

JRESGOVSOP0058 SoECAT Validation V1.0_04.04.2023 (PDF)

JRESGOVSOP0059 Safety Reporting for Clinical Investigations of a Medical Device V1.0_17.10.2023 (PDF)

Templates and logs

JRESDOC0001 Interventional Study Protocol Template V14.0_09.08.2024 (Word)

JRESDOC0002 Non-Interventional Protocol Template V13.0_09.08.2024 (Word)

JRESDOC0003 CTIMPs TMF Index (Word)

JRESDOC0004 CTIMPs and Devices ISF index (Word)

JRESDOC0008 CTIMP PIS Template (Word)

JRESDOC0009 CTIMP ICF Template(Word)

JRESDOC0011 CV Template (Word)

JRESDOC0012 SAE Reporting Form (Word)

JRESDOC0029 File Note Template (Word)

JRESDOC0033 Pregnancy Reporting Form (Word)

JRESDOC0040 Self Monitoring Form (Word)

JRESDOC0046 DSUR Template (Word)

JRESDOC0047 24hrs Safety Card Template (Word)

JRESDOC0048 Protocol Acknowledgement Form (Word)

JRESDOC0059 End of Study Report Template (Word)

JRESDOC0061 Deviation reporting form (Word)

JRESDOC0069 Non CTIMP PIS Template (Word)

JRESDOC0070 Non CTIMP ICF Template (Word)

JRESDOC0076 UK and International TMF Index (Word)

JRESDOC0076a International Only Studies (no UK sites) TMF Index (Word)

JRESDOC0083 Site Feasibility Checklist Form (Word)

JRESDOC0086 GP Letter Template V4 2024 (Word)

JRESDOC0094 Peer Reviewer Feedback Form V4.0 14.08.2024 (Word)

JRESDOC0103 Non-CTIMP ISF Index (Word)

JRESDOC0106 Notification of Serious Breach Timeline and Actions Taken(Word)

JRESDOC0111 Sample Storage Box Map (Word)

JRESDOC0113 ICF Pregnancy Follow Up (Word)

JRESDOC0114 Pregnant Partner PIS Template (Word)

JRESDOC0116 Trial Steering Committee Charter (Word)

JRESDOC0116a Data Monitoring Committee Charter (Word)

JRESDOC0123 St Georges Research DPIA (Word)

JRESDOC0125 IB Template (Word)

JRESDOC0126 CRF Template (Word)

JRESDOC0128 PI Responsibilities Agreement - CTIMPs (Word)

JRESDOC0130 CAPA Plan (Word)

JRESLOG0001 Screening and Enrolment Log (Word)

JRESLOG0002 Subject ID log (Word)

JRESLOG0004 Staff Delegation of Duties log (Word)

JRESLOG0006 Study Amendments log (Word)

JRESLOG0007 Adverse Events Log (Word)

JRESLOG0008 Monitoring Visit log (Word)

JRESLOG0009 SOP Reading log (Word)

JRESLOG0011 Data Query Log (Word)

JRESLOG0012 Sample Collection Log (Word)

JRESLOG0012a Sample Destruction Log (Word)

JRESLOG0014 GP letter log (Word)

JRESLOG0015 Telephone Call Log (Word)

JRESLOG0016 Study Training log (Word)

JRESLOG0018 CVs and GCP Certs (Word)

JRESLOG0022 File Note Log (Word)

JRESLOG0023 Reconsenting Log (Word)

JRESLOG0024 Withdrawal Log (Word)

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