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SOP downloads – sponsor

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

SOP Reference Number

SOP Title

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-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-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 2 – Peer Review
Appendix 3 – Sponsor Guidance Form

S-1003: SOP UHL Sponsor risk assessment and management

Appendix 1 - Risk Matrix Score Tables

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

Appendix 7 - UHL Multi-centre 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

Appendix 2 - UHL Multi-centre Checklist

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-1024: UHL Study Closedown Appendix 1 - UHL Site Close Down Report Template
Appendix 1a - Report Non CE Marked Medical Devices Studies Template
Appendix 2  - Visit Log
Appendix 3 - Checklist for Non CTIMP Studies
Appendix 3a - Checklist for CE Marked Device Studies

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-1030: SOP UHL End of Study Appendix 1 - 1 Month Pre Due Date Reminder
Appendix 2 - Due Date Email Reminder
Appendix 3 - 1 Month Post Due Date Email Reminder
Appendix 4 - EoS Report Acknowledgement

S-1031: SOP for Data Management

Appendix 1 – Blank DoA Signature Log

Appendix 2 - Data Management Flow Chart

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-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 1A - Checklist CI site

Appendix 1B - 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
Appendix 7 - Completion Request (Multi-Centre)
Appendix 8 - Reminder 1 Month (Single Site)
Appendix 9 - Reminder 1 Month (Multi-Site)
Appendix 10 - Reminder 2 Months (Single Site)
Appendix 11 - Reminder 2 Months (Multi-Site)
Appendix 12 - Request for Further Information
Appendix 13 - Acknowledgement of Completed Sponsor Green Light Checklist

SOP S-1047 – Re-Opening Process During Pandemic for Sponsored Studies

Appendix 1 – UHL Pandemic Response