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 1000: SOP for writing standard operating procedures for research and development

This SOP is to provide method sheets sufficiently detailed to be unambiguous, but not so detailed and inflexible that continuous amendments are required.  They are intended to outline the processes and/or procedures for a given purpose or policy application.

S-1002: SOP for documentation review process

This SOP describes the process that the Research and Innovation team will follow when conducting initial documentation reviews. This occurs prior to confirmation that Leicester’s Hospitals will act as the Sponsor organisation.

This SOP has some appendices, which are:

SOP S-1002 & S-1014 Appendix 1 – Sponsor Request Form

SOP S-1002 Appendix 2 – Peer Review

S-1003: SOP for sponsor risk assessment and management of research

This SOP describes the procedures used by the Research and Innovation team when completing a Sponsor Risk Assessment, compiling a mitigation plan and completing the Sponsor Green Light Process.

This SOP has some appendices, which are:

SOP S-1003 Appendix 1 – Risk Matrix Score Tables

SOP S-1003 Appendix 2 – Risk Assessment Form

SOP S-1003 Appendix 4 – Risk Assessment Flow Chart

SOP S-1003 Appendix 5 – UHL Sponsor Review  Risk Assessed Studies Checklist

SOP S-1003  Appendix 6 – Sponsor Review Non Risk Assessed Checklist

SOP S-1003 Appendix 7 – UHL Sponsor review assessment feedback

S-1004: SOP for development safety update report for CTIMPS

This SOP describes the procedures used by the Research and Innovation team for the preparation and timely reporting of the Development Update Safety Report. This report is specifically for Clinical Trials of Investigational Medicinal Product Studies (CTIMPS).

This SOP has some appendices, which are:

SOP S-1004 Appendix 1 – DSUR Template

SOP S-1004 Appendix 2 – DSUR Reporting Timeframe Working Illustration

SOP S-1004 Appendix 3 – DSUR Reporting Timeframe Working Instructions

S-1005: SOP for management of contracts

This SOP describes the procedures used by the Research and Innovation team when providing and managing agreements with third parties, where Leicester’s Hospitals is the Sponsor.

SOP S-1005 Appendix 1 UHL Contracts Review and Approval Process

S-1006: SOP for informed consent

This SOP describes the process of obtaining informed consent from a study subject for all research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1006 Appendix 1 – Blank DoA Signature Log

SOP S-1006 Appendix 2 – Assent Signature Log

SOP S-1006 Appendix 3 – Assent Consent Log

SOP S-1006 Appendix 4 – Witness Consent Form Template

SOP S-1006 Appendix 5 Consent Witness Statement

SOP S-1006 Appendix 6 – Pre-Consent activity proforma

S-1007: SOP for management (monitoring) of research

This SOP describes the procedures for management of a study site undertaking research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1007 Appendix 1 – Monitoring Plan Template

SOP S-1007 Appendix 2 – Monitoring Strategy Table

SOP S-1007 Appendix 3 – Contact Monitoring Log

SOP S-1007 Appendix 4 – Trial Monitoring Visit Log

SOP S-1007 Appendix 5 – Investigator Schedule of Source Data

SOP S-1007 Appendix 6 – Monitoring Visit Report

SOP S-1007 Appendix 7 – Pharmacy visit report

SOP S-1007 Appendix 8 Non-CTIMP Interim Site Audit checklist & Response

S-1008: SOP for training for staff engaged in research

This SOP describes the minimum training requirements for personnel involved in research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1008 Appendix 1 & SOP S-1011 Appendix 3 – SOPs Read Log for UHL Sponsored Studies

SOP S-1008 Appendix 2 & S-1021 Appendix 3 – Protocol Training Log

S-1009: SOP for processing and reporting of SAE, SAR & SUSAR

This SOP describes the process required by Leicester’s Hospitals for the identifying, reporting and documenting of all adverse events and reactions where the Trust is the Sponsor. These events and reactions are classed as: Serious Adverse Event (SAE), Serious Adverse Reaction (SAR) and Suspected Unexpected Serious Adverse reaction (SUSAR).

This SOP has several appendices, which are:

SOP S-1009 Appendix 1 – Pregnancy Reporting Form

SOP S-1009 Appendix 2 – Multicentre Line Listing

SOP S-1009 Appendix 3 – SAE LOG

SOP S-1009 Appendix 4 – SAE Review Process Flowchart

SOP S-1009 Appendix 5 – SAE Amendment Request Form

SOP S-1009 Appendix 6 – Multi-Centre line listing template for CTIMPs V7

SAE Guidelines – Form A

SOP S-1009 Form A – SAE Reporting Form (CTIMP)

SAE Guidelines – Form B

SOP S-1009 Form B – SAE Reporting Form (Non-CTIMP)

S-1010: SOP for chief investigator responsibilities

This SOP describes the role and responsibilities of the Chief Investigator of a research study sponsored by Leicester’s Hospitals.

This SOP has an appendix, which is:

SOP S-1010 Appendix 1 – Roles and Responsibilities of CI Agreement

S-1011: SOP for site initiation of CTIMP research

This SOP describes the procedures for initiation of all CTIMP research studies sponsored by Leicester’s Hospitals.

This SOP has several appendices, which are:

SOP S-1011 Appendix 1 – Site Initiation Checklist & Outstanding Issues Report

SOP S-1011 Appendix 2 Pharmacy Initial Visit Checklist

SOP S-1011 Appendix 3 & S-1008 Appendix 1 – SOP Read Log

SOP S-1011 Appendix 4 Subject Screening Log

SOP S-1011 Appendix 5 – Subject Enrolment Log

SOP S-1011 Appendix 6 – Site Initiation Checklist Non-CTIMP

Sutstanding-Issues-Report-non-CTIMP-Version-9-Feb-OP S-1011 Appendix 7 – Site Initiation Checklist Non-CTIMP Guidance

S-1012: SOP for management and production of corrective and preventative action plan

This SOP describes the process to be followed when breaches/deviations of research Protocol, Good Clinical Practice (GCP), Sponsor/Host SOPs or agreements have been identified. A Corrective and Preventative Action Plan (CAPA) must be completed on each occasion.

This SOP has some appendices, which are:

SOP S-1012 Appendix 1 – CAPA Form

SOP S-1012 Appendix 2 – CAPA Tracking Log

S-1013: SOP for identifying and reporting deviations and serious breaches of GCP and/or the protocol for clinical trials

This SOP describes the process for the identification and reporting of serious breaches of GCP and/or the approved trial protocol in all research studies sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1013 Appendix 1 – Serious Breach Notification Form

SOP S-1013 Appendix 2 – Template File Note

SOP S-1013 Appendix 3 – Protocol Deviation Tracking Log

S-1014: SOP for green light process

This SOP describes the procedures used by the Research and Innovation team when completing the Sponsor Green Light Process.

This SOP has several appendices, which are:

SOP S-1014 Appendix 1 – Green Light Process First Site

SOP S-1014 Appendix 2 – Multi Centre Site Sponsor Green Light

SOP S-1014 Appendix 3 – Contracts Agreements Listing

S-1015: SOP for management of essential documents and trial filing

This SOP describes the creation of an audit trail through the retention of essential documents in the Trial Master File (TMF) or Investigator Site File (ISF) for all research studies sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1015 Appendix 1 – TMF ISF Contents (CTIMP)

SOP S-1015 Appendix 2 – TMF ISF Contents (Non-CTIMP)

SOP S-1015 Appendix 3 – Version Control Document

S-1016: SOP for procedure in the event of non-compliance

This SOP describes the process of responding to any form of non-compliance identified in research studies sponsored by Leicester’s Hospitals. This includes: audit findings, protocol violations, contractual issues and whistleblowing (not requiring the implementation of SOP S-1019).

S-1017: SOP for green light process amendments

This SOP describes the procedures used by the Research and Innovation team when completing the Sponsor Green Light Process for amendments to research that has previously received formal approvals.

This SOP has several appendices, which are:

SOP S-1017 Appendix 1 – List of Amendments Requiring MHRA Authorisation Only

SOP S-1017 Appendix 2 – List of Amendments Requiring MHRA and REC Authorisation

SOP S-1017 Appendix 3 – List of Amendments Requiring REC Favourable Opinion

SOP S-1017 Appendix 4 – Amendments Not Normally Requiring Notification

SOP S-1017 Appendix 5 – Multi Centre Site Sponsor Amendment Green Light Process Form

SOP S-1017 Appendix 6 – First/Single Site Sponsor Amendment Green Light Process

S-1018: SOP for approval of amendments or additions to documents

This SOP details Leicester’s Hospitals procedures for managing amendments in research studies where the trust is the Sponsor.

S-1019: SOP for procedure for the management of suspected fraud and misconduct

This SOP describes the procedures required for management of suspected fraud and misconduct within research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1019 Appendix 1 – Suspected Fraud or Misconduct Initial Investigation Template

SOP S-1019 Appendix 2 – Suspected Fraud or Misconduct Interview Template

SOP S-1019 UHL Appendix 3 – Evidence Listing Template

S-1020: SOP for process of assessing site feasibility

This SOP defines the procedure to be used when identifying sites to undertake research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1020 Appendix 1 – Site Feasibility Assessment

SOP S-1020 Appendix 2 – Site Feasibility

S-1021: SOP for process of writing study protocols

This SOP defines the requirements for the format and content of study protocols for research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1021 Appendix 3 & SOP S-1008 appendix 2 – Protocol Training Log

S-1022: SOP for process of submission of annual progress reports

This SOP describes the procedures for managing the submission of Annual Progress Reports (APRs) for research sponsored by Leicester’s Hospitals.

S-1023: SOP for investigators brochure (IB)/summary of product characteristics (SPC) preparation, review, approval and amendment

This SOP has some appendices, which are:

SOP S-1023 Appendix 1 – Investigators Brochure Contents Template

SOP S-1023 Appendix 2 – Investigators Brochure Review template

S-1024: SOP for study close down

This SOP describes the procedures for reporting and documentation requirements  for the closure of research sponsored by Leicester’s Hospitals.

This SOP has some appendices, which are:

SOP S-1024 Appendix 1 – Site Close Down Report

SOP S-1024 Appendix 2 – Site Close Down Visit Log

SOP S-1024 Appendix 3 UHL Site Closedown Checklist for UHL Sponsored Non CTIMP Studies

S-1025: SOP for convening a data safety monitoring committee

This SOP describes the process to be adopted when convening a Data Safety Monitoring Committee/Board for research sponsored by Leicester’s Hospitals.

This SOP has an appendix, which is:

SOP S-1025 Appendix 1 – Data Safety Monitoring Committee Charter Template

S-1026: SOP for urgent safety measures

This SOP details the procedures to be followed by the Sponsor, Chief/Principal Investigators or research teams where Urgent Safety Measures (USM) are required to protect study objects against any immediate hazard to their health and/or safety in studies sponsored by Leicester’s Hospitals.

SOP S-1026 Appendix 1 – Urgent Safety Measures Template

S-1027: SOP for creating a statistical analysis plan (SAP)

This SOP defines the procedure for the production of a Statistical Analysis Plan (SAP) for sponsored research by Leicester’s Hospitals.

S-1028: SOP for managing amendments to contracts

This SOP describes the procedures used by Leicester’s Hospitals for sponsored research when managing amendments to agreements with Third Parties.

S-1029: SOP for archiving of essential documents

This SOP describes the requirements for archiving all sponsored research by Leicester’s Hospitals.

SOP S-1029 Appendix 1 – Archiving Facility Checklist

SOP S-1029 Appendix 2 – Archiving Electronic Aspects of  TMF 

SOP S-1029 Appendix 3 – Pre-Archiving Checklist

SOP S-1029 Appendix 4 – Archiving process flowchart

SOP S-1029 Appendix 5 – Retrieval process flowchart

SOP S-1029 Appendix 6-Archiving-Guidance-Timetable

SOP S-1029 Form A

SOP S-1029 Form B

SOP S-1029 Form C

S-1030: SOP for end of study reporting requirements

This SOP describes the processes required at the end of a study.

S-1031: SOP for data management process

This SOP is to provide guidance for managing data and ensuring all data are collected, verified and analysed in the appropriate manner for research studies sponsored by Leicester’s Hospitals.

SOP S-1032 Vendor Selection

S-1033: SOP for randomisation and blinding

This SOP is to outline the process required when research includes wither or both Randomisation and Blinding.

S-1034: SOP for obtaining finance approval

This SOP describes the requirements for obtaining finance approval for all research sponsored by Leicester’s Hospitals.

S-1035: SOP for case report form production

This SOP is to standardise the approach for designing Case Report Forms (CRFs) for sponsored research by Leicester’s Hospitals.

SOP S-1035 Appendix 1 Case Report Form Template

SOP S-1035 Appendix 2 A guide to designing a case report form

SOP S-1036 UHL Audit

S-1037: SOP for management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics of investigational medicinal products

This SOP details the steps required when conducting Clinical Trials of Investigational Medicinal Products with Healthy Volunteers when research activity investigates any or all of Absorption, Distribution, Metabolism and Excretion (ADME) studies.

SOP S-1037 Appendix 1 – TOPS Consent Form Template