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 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-1043Research Publications and Dissemination for all research sponsored by UHL
SOP Reference Number & Title   Appendix Title      
S-1002: SOP UHL Documentation review process Appendix 1 – Sponsor Request Form
Appendix 2 – Peer Review
S-1003: SOP UHL Sponsor risk assessment and management Appendix 1 – Risk Matrix Score Tables
Appendix 2 – 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
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
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 1 – Investigators Brochure Contents Template
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 essential documents Appendix 1 – Archiving Facility Checklist
Appendix 2 – Archiving Electronic Aspects of  TMF 
Appendix 3 – Pre-Archiving Checklist
Appendix 4 – Archiving process flowchart
Appendix 5 – Retrieval process flowchart
Appendix 6 – Archiving-Guidance-Timetable
Form A
Form B
Form C
Form D
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