SOP downloads – sponsor

The documents on this page are for those studies where Leicester’s Hospitals is the Sponsor organisation.

Index of Standard Operating Procedures for all research Sponsored by the University Hospitals of Leicester

SOP Reference Number	SOP Title
S-1000	UHL SOP for writing SOPs
S-1002	UHL Documentation review process
S-1003	UHL Sponsor risk assessment and management
S-1004	SOP for development safety update report for CTIMPS
S-1005	SOP for management of contracts
S-1006	SOP for informed consent
S-1007	UHL Monitoring
S-1008	UHL Training for Staff Engaged in Research
S-1009	UHL SAEs_SUSARS
S-1010	UHL Chief Investigator Responsibilities
S-1011	SOP for site initiation of CTIMP research
S-1012	UHL CAPA
S-1013	UHL Serious Breaches
S-1014	UHL Sponsor Green Light Process for research sponsored by UHL
S-1015	UHL Essential Documents
S-1016	UHL Procedure in event of non-compliance
S-1017	UHL Green Light Process for Amendments
S-1019	Procedure for the management of suspected fraud and misconduct
S-1020	Process of assessing site feasibility
S-1021	Process of writing study protocols
S-1022	Process of submission of annual progress reports
S-1023	Investigators brochure (IB)/summary of product characteristics (SPC) preparation, review, approval and amendment
S-1024	Study close down
S-1025	Convening a data safety monitoring committee
S-1026	Urgent safety measures
S-1027	Creating a statistical analysis plan (SAP)
S-1028	Managing amendments to contracts
S-1029	Archiving of paper hybrid TMF Essential Documents
S-1030	End of study reporting requirements
S-1031	Data management process
S-1032	Vendor Selection
S-1033	Randomisation and blinding
S-1034	Obtaining finance approval
S-1035	Case report form production
S-1036	UHL Audit
S-1037	Management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics of investigational medicinal products
S-1038	Processing and Reporting SAEs, SADEs and USADEs for Medical Device Studies
S-1039	Sample management for research studies sponsored by UHL
S-1040	UHL Safety Reporting NON CE Marked Devices
S-1041	UHL Safety Reporting for CE Marked Devices
S-1042	EDGE where UHL Sponsor
S-1043	Transparency for Research Sponsored by UHL
S-1045	End of Sponsor Green Light
S-1047	Re-Opening Process During Pandemic for Sponsored Studies
SOP Reference Number & Title	Appendix Title
S-1002: SOP UHL Documentation review process	Appendix 1 – Sponsor Request Form Appendix 2 – Peer Review Appendix 3 – Sponsor Guidance Form
S-1003: SOP UHL Sponsor risk assessment and management	Appendix 2 – UHL Risk Assessment Form Appendix 4 – Risk Assessment Flow Chart Appendix 5 – UHL Sponsor Review  Risk Assessed Studies Checklist Appendix 6 – Sponsor Review Non-Risk Assessed Checklist
S-1004: SOP for development safety update report for CTIMPS	Appendix 1 – DSUR Template Appendix 2 – DSUR Reporting Timeframe Working Illustration Appendix 3 – DSUR Reporting Timeframe Working Instructions
S-1005: SOP for management of contracts	Appendix 1 – UHL Contracts Review and Approval Process
S-1006: SOP for informed consent	Appendix 1 – Blank DoA Signature Log Appendix 2 – Assent Signature Log Appendix 3 – Assent Consent Log Appendix 4 – Witness Consent Form Template Appendix 5 Consent Witness Statement Appendix 6 – Pre-Consent activity proforma Appendix 7 – eSignature Log
SOP S-1007 UHL Monitoring	Appendix 1 – Monitoring Plan Template Appendix 1a – Monitoring Plan Template Medical Devices Appendix 2 – Monitoring Strategy Table Appendix 3 – Contact Monitoring Log Appendix 4 – Trial Monitoring Visit Log Appendix 5 – UHL Template Schedule Source Data Appendix 6 – CTIMP Monitoring Visit Report Appendix 6a – Monitoring Visit Report Non CE Marked Medical Devices Appendix 7 – Pharmacy visit report Appendix 8 –  Non-CTIMP Interim Site Audit checklist & Response Appendix 8a – CE Marked Medical device Interim Site Audit checklist & Response Doc
SOP S-1008 UHL Training for Staff Engaged in Research	Appendix 1 – SOPs Read Log for UHL Sponsored Studies Appendix 2 – Protocol Training Log Appendix 3 – CTIMP SOP generic list Appendix 4 – Non-CTIMP SOP generic list
SOP S-1009 UHL SAEs_SUSARS	Appendix 1 – Pregnancy Reporting Form Appendix 2 – Multicentre line listing Appendix 3 – SAE Tracking Log Appendix 4 – UHL SAE Process Flowchart Appendix 5 – Template Sponsor SAE Email Appendix 6 – Multicentre line listing CTIMP Appendix 7 – eSUSAR Guidance Appendix 8 – UHL SUSAR Process Flowchart Appendix 9 – UHL Expedited Safety Report Notification Email Appendix 10 – UHL Suspected SUSAR Unblinding Process Flowchart UHL SAE Form A Completion Guidance Document CTIMP UHL SAE Form B Completion Guidance Document Non-CTIMP UHL SAE Reporting Form A CTIMP  UHL SAE Reporting Form B Non CTIMP
SOP S-1010 UHL Chief Investigator Responsibilities	Appendix 1 – Roles and Responsibilities of CI Agreement
SOP S-1011: SOP for site initiation of CTIMP research	Appendix 1a – Site Initiation Checklist & Outstanding Issues Report Appendix 2 – Pharmacy Site Initiation Visit Checklist Appendix 3 – SOP Read Log for UHL Sponsored Studies Appendix 4 – Subject Screening Log Appendix 5 – Subject Enrolment Log Appendix 6 – Site Initiation Checklist & Outstanding Issues Report Non-CTIMP Appendix 6a – UHL Site Initiation Checklist & Outstanding Issues Report – CE Marked Medical Device Studies Appendix 7 – Site Initiation Checklist Guidance Non-CTIMP Appendix 7a – Site Initiation Checklist Guidance – CE Marked Medical Device Studies Appendix 8 – Investigational Medical Device Accountability Log
SOP S-1012 UHL CAPA	Appendix 1 – CAPA Form
SOP S-1013 UHL Serious Breaches	Appendix 1 – Serious Breach Notification form Appendix 2 – Template file note Appendix 3 – Protocol Deviation Tracking Log
SOP S-1014 UHL Sponsor Green Light Process for research sponsored by UHL	Appendix 1 – Green Light Process First Site Appendix 2 – Multi Centre Site Sponsor Green Light Appendix 3 – Contracts Agreements Listing
SOP S-1015 UHL Essential Documents	Appendix 1 – TMF ISF Contents CTIMP Appendix 1a TMF Non CE Marked Medical Device Studies Appendix 2 – TMF ISF Contents non CTIMP Appendix 2a – TMF ISF Contents Index for CE Marked and Proof of Concept Studies Appendix 3 – Version Control Doc Appendix 4 – File retention recommendations
SOP S-1017 UHL Green Light Process for Amendments	Appendix 1 – Amendments requiring MHRA authorisation only Appendix 2 – Amendments requiring MHRA & REC authorisation Appendix 3 – Amendments requiring REC favourable opinion Appendix 4 – Amendments not normally requiring notification
S-1019: Procedure for the management of suspected fraud and misconduct	Appendix 1 – Suspected Fraud or Misconduct Initial Investigation Template Appendix 2 – Suspected Fraud or Misconduct Interview Template Appendix 3 – Evidence Listing Template
S-1020: Process of assessing site feasibility	Appendix 1 – Site Feasibility Assessment Appendix 2 – Site Feasibility
S-1021: Process of writing study protocols	Appendix 3 – Protocol Training Log
S-1023: Investigators brochure (IB)/summary of product characteristics (SPC) preparation, review, approval and amendment	Appendix 2 – Investigators Brochure Review template
S-1024: Study close down	Appendix 1 – Site Close Down Report Template Appendix 1a – Site Close Down Report Non CE Marked Medical Device Studies Template Appendix 2 – Site Close Down Visit Log Appendix 3 – UHL Site Close Down Checklist for UHL Sponsored Non CTIMP Studies Appendix 3a – UHL Site Close Down Checklist for UHL Sponsored CE Marked Device Studies
S-1025: Convening a data safety monitoring committee	Appendix 1 – Data Safety Monitoring Committee Charter Template
S-1026: Urgent safety measures	Appendix 1 – Urgent Safety Measures Template
S-1029: SOP for Archiving of paper hybrid TMF Essential Documents	Appendix 1 – Archiving Facility Checklist Appendix 2 – Pre-Archiving Checklist Appendix 3 – Archiving Process Flowchart Appendix 4 – Retrieval Process Flowchart Appendix 5 – Archiving Guidance Timetable Appendix 6 – Sponsor Expiry of Archiving Period Notification Appendix 7 – Sponsor Archiving Period Notification Appendix A Appendix B Appendix C Appendix D Retention Schedules
S-1031: SOP for Data Management	Appendix 1 – Blank DoA Signature Log
S-1035: SOP for case report form production	Appendix 1 – Case Report Form Template Appendix 2 – A guide to designing a case report form
S-1037: SOP for management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics of investigational medicinal products	Appendix 1 – TOPS Consent Form Template
SOP S-1038 SOP Processing and Reporting SAEs, SADEs and USADEs for Medical Device Studies	Appendix 1 – Event Categorisation Flow Chart Appendix 2 – Adverse event Adverse Effect record Appendix 3 – Serious Adverse Event Report Form C Appendix 4 – Multicentre line listing Appendix 5 – MHRA reporting timelines table Appendix 6 – UHL Medical Device Process Flowchart Appendix 7 – Template SAE SADE Follow Up Information Request Email
SOP S-1039 Sample management for research studies sponsored by UHL	Appendix 1a – FRIDGE Temperature Log Appendix 1b – FREEZER Temperature Log Appendix 1c – NITROGEN Log Appendix 2 – Sample Tracking Log Appendix 3 – Sample End of Study Sponsor Form Appendix 4 – Shipping Instructions for Biological Samples Appendix 5 – Human Tissue Disposal Form
SOP S-1040 UHL Safety Reporting NON CE Marked Devices	Appendix 1 – Event Categorisation Flow Chart Appendix 2 – Adverse Event Adverse Effect Record Appendix 3 – SAE Report Form C Appendix 4 – SAE Form C Completion Guidance Document Appendix 5 – Medical Device Sponsor Process Flowchart Appendix 6 – Template SAE SADE Follow Up Information Request Email Appendix 7 – Device Deficiency Form
SOP S-1041 Medical Device Studies Safety Reporting (NOT requiring MHRA approval)	Appendix 1 – Event Categorisation Flow Chart Appendix 2 – Adverse Event Adverse Effect Record Appendix 3 – SAE Report Form C Appendix 4 – SAE Form C Completion Guidance Document Appendix 5 – Multicentre Line Listing Appendix 6 – Medical Device Sponsor Process Flowchart Appendix 7 – Template SAE SADE Follow Up Information Request Appendix 8 – Device Deficiency Form
SOP S-1045 – End of Sponsor Green Light	Appendix 1 – Checklist Appendix 2 – 6 Month Email Reminder Appendix 3 – 9 Month Email Reminder Appendix 4 – 10 Month Email Reminder Appendix 5 – 11 Month Email Reminder Appendix 6 – Receipt of Completed Sponsor Green Light Checklist
SOP S-1047 – Re-Opening Process During Pandemic for Sponsored Studies	Appendix 1 – UHL Pandemic Response