Research Policies and Templates for Sponsors

In the table below, you will find a list of resources for research sponsored by the University Hospitals of Leicester NHS Trust (UHL). These include Standard Operating Procedure documents (SOPs) and template forms. You can use the links in the table to access the relevant materials.

R&I Reference	Trust Reference	SOP Title and Link	Associated Resources
S-1002	B65/2024	Sponsorship Review and Approval	Appendix 1 – Sponsorship Review and Approval – Peer Review Form Appendix 2 – Sponsorship Review and Approval – Overview
S-1004	C20/2013	DSUR in Sponsored Research	Appendix 1 – DSUR Template Appendix 2 – Development Safety Update Reporting Timeframe Appendix 3 – Development Safety Update Reporting Timeframe Guidance Document
S-1006	C11/2014	Informed Consent for Research	Appendix 1 – Blank DoA Signature Log Appendix 2 – Assent Signature Log Appendix 3 – Assent/Consent Log Appendix 4 – Witness Consent Form Appendix 5 – Consent Process Witness Statement Appendix 6 – Pre-Consent Agreement – Fasting Appendix 7 – Signature Log for Use in Conjunction with EDGE DoA
S-1007	C16/2013	Standard Operating Procedure for Management (Monitoring) of Research Sponsored by University Hospitals of Leicester NHS Trust (UHL)	Appendix 1 – Study Monitoring Plan Template Appendix 1a – Study Monitoring Plan Template – Non CE/CE Marked Medical Device Studies Appendix 2 -Trial Risk Based Monitoring Guidelines for CTIMP Studies Appendix 3 – Contact Monitoring Log Study Number Appendix 4 -Trial Monitoring Visiting Log Appendix 5 – Investigator Schedule of Source Data Appendix 6 – UHL Monitoring Visit Report for UHL Sponsored CTIMP Trials Appendix 6a – UHL Monitoring Visit Report for UHL Sponsored Non CE Marked Medical Device Studies Appendix 7 – UHL Pharmacy Visit Report Appendix 8 – UHL Non-CTIMP Monitoring/Audit Checklist Appendix 8a -UHL CE Marked/ Proof of Concept Medical Device Studies Monitoring/Audit Checklist
S-1009	B7/2025	Safety Reporting For UHL Sponsored Research (CTIMPs And Other Studies)
S-1011	C17/2013	Site Initiation in Sponsored Research in UHL	Appendix 1a – UHL Site Initiation Checklist for CTIMP Studies Appendix 2 – UHL Pharmacy Initial Visit Checklist Appendix 3 – Standard Operation Procedures Read Log for UHL Sponsored Studies Appendix 4 – Subject Screening Log Appendix 5 – Subject Enrolment Log Appendix 6 – UHL Site Initiation Checklist for Studies Not Involving Investigational Medicinal Products Appendix 6a – UHL Site Initiation Checklist for CE Marked or Proof of Concept Medical Device Studies Appendix 7 – Site Initiation Checklist Guidance for Non CTIMP Studies Appendix 7a – Site Initiation Checklist Guidance for CE Marked or Proof of Concept Medical Device Studies Appendix 8 – Investigational Medical Device Accountability Log
S-1012	C13/2014	Management & Production of CAPA in Sponsored Research in UHL	Appendix 1 – Corrective Action Preventative Action (CAPA) Form
S-1013	C16/2014	Standard Operating Procedure for Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol/Clinical Investigation Plan for Clinical Trials Sponsored by University Hospitals of Leicester NHS Trust (UHL)	Appendix 1 – Serious Breach Notification Form Appendix 2 – Site File Note Appendix 3 – Protocol/Clinical Investigation Plan (CIP) Deviation Tracking Log
S-1016	C19/2014	Standard Operating Procedure for Procedure in the Event of Non-Compliance in Research Sponsored by University Hospitals of Leicester NHS Trust (UHL)
S-1020	C32/2014	Site Feasibility in Sponsored Research in UHL Research & Innovation	Appendix 1 – Site Feasibility Assessment Appendix 2 – Pharmacy Feasibility
S-1022	C34/2014	Process for Annual Reports in Sponsored Research in UHL Research & Innovation
S-1023	C35/2014	IB Prep Review in Sponsored Research in UHL Research & Innovation	Appendix 2 – Investigator’s Brochure/IMPD/sIMP/SPC Review Template
S-1024	C27/2014	Site/s Closedown in Sponsored Research in UHL Research & Innovation	Appendix 1 – UHL Site Closedown Report for UHL CTIMP Studies Appendix 1a – UHL Site Closedown Report for UHL Non UKCA/CE Marked Medical Device Studies Appendix 2 – UHL Site Closedown Visit Log Appendix 3 – Site Closedown Checklist for UHL Sponsored Non CTIMP Studies Appendix 3a – Site Closedown Checklist for UHL Sponsored UKCA/CE Marked Medical Device Studies
S-1025	C28/2014	Convening a Data Safety Monitoring Committee for Sponsored Research in UHL Research & Innovation	Appendix 1 – Data Safety Monitoring Committee Charter for University Hospitals of Leicester NHS Trust Sponsored Research
S-1026	C29/2014	Urgent Safety Measures in Sponsored Research in UHL Research & Innovation	Appendix 1 – Urgent Safety Measures Template
S-1027	C30/2014	Creating a SAP in Sponsored Research in UHL Research & Innovation
S-1030	C38/2014	End of Study Reporting in Sponsored Research in UHL Research & Innovation	Appendix 1 – 1-Month Prior to Due Date Reminder Appendix 2 – Due Date Reminder Appendix 3 – 1 Month Post Due Date Reminder Appendix 4 – End of Study Declaration Acknowledgement
S-1031	C39/2014	Data Management in Sponsored Research in UHL Research & Innovation	Appendix 1 – Delegation of Authority and Signature Log Appendix 2 – Data Management Flow Chart
S-1032	C2/2017	Vendor Selection in Sponsored Research in UHL Research & Innovation
S-1035	C41/2014	Case Report Form Production in Sponsored Research in UHL Research & Innovation	Appendix 1 – Case Report Form Appendix 2 – A Guide to Designing a Case Report Form
S-1036	C6/2017	Quality Assurance (Audit) in Sponsored Research in UHL Research & Innovation
S-1037	C1/2015	Healthy Volunteers in Sponsored Research in UHL Research & Innovation	Appendix 1 – TOPS Consent Form Template
S-1039	C72/2017	Sample Management in Sponsored Research in UHL Research & Innovation	Appendix 1a – Fridge Temperature Log Appendix 1b – Freezer Temperature Log Appendix 1c – Nitrogen Vessel Storage Log Appendix 2 – Sample/Tissue Tracking Log Appendix 3 – Sponsor Study Sample/Tissue End of Study Notification Form Appendix 4 – Packaging Requirements for the Transport of Biological Samples/Tissue Appendix 5 – Human Tissue Act 2004 Standard Form for Human Tissue Disposal
S-1040	B15/2021	Safety Reporting Non CE Marked Devices In Sponsored UHL Research (MHRA Regulated Device Trials)
S-1043	B12/2021	Transparency and Publication of Research Sponsored by UHL Research & Innovation
S-1045	B13/2021	End of Sponsor Green Light Process for Sponsored Research in UHL Research & Innovation

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