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 UHL SOP for writing SOPs V9 April 2018

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 UHL Documentation review process v7 January 2018

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 UHL Sponsor risk assessment and management v7 January 2018

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

 

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

SOP S-1006 Appendix 7 eSignature Log V9 April 2018 JJ

SOP S-1007 UHL Monitoring V9 January 2018

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:

Appendix 1 – SOP S-1007 Monitoring Plan Template V9 Jan 18

Appendix 2 – SOP S-1007 Monitoring Strategy Table V9 Jan 18

Appendix 3 – SOP S-1007 Contact Monitoring Log V9 Jan 18

Appendix 4 – SOP S-1007 Trial Monitoring Visit Log V9 Jan 18

Appendix 5 – SOP S-1007 UHL Template Schedule Source Data V9 Jan 18

Appendix 6 – SOP S-1007 Monitoring Visit Report V9 Jan 18

Appendix 7 – SOP S-1007 Pharmacy visit report V9 Jan 18

Appendix 8 – SOP S-1007 Non-CTIMP Interim Site Audit checklist & Response Doc V9 Jan 18

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

SOP S-1008 UHL Training for Staff Engaged in Research V7 March 2017

SOP S-1009 UHL SAEs_SUSARS_V9 June 2018

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 FINAL Pregnancy Reporting Form V9 June 2018

SOP S-1009 Appendix 2 Multicentre line listing V9 June 2018

SOP S-1009 Appendix 3 SAE Tracking Log V9 June 2018

SOP S-1009 Appendix 4 UHL SAE Process Flowchart V9 June 2018

SOP S-1009 Appendix 5 Template Sponsor SAE Email V9 June 2018

SOP S-1009 Appendix 6 Multicentre line listing CTIMP V9 June 2018

SOP S-1009 Appendix 7 eSUSAR Guidance V9 June 2018

SOP S-1009 UHL SAE Form A Completion Guidance Document CTIMP V9 June 2018

SOP S-1009 UHL SAE Form B Completion Guidance Document Non-CTIMP V9 June 2018

SOP S-1009 UHL SAE Reporting Form A CTIMP V9 June 2018

SOP S-1009 UHL SAE Reporting Form B Non CTIMP V9 June 2018

UHL SAE Review Process Flowchart v 9 June 2018 (new)

SOP S-1010 UHL Chief Investigator Responsibilities V10 August 2018

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 Reponsibilities of CI Agreement – V10 August 2018

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

SOP S-1012 UHL CAPA V7 January 2018

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 V7 January 2018

SOP S-1012 Appendix 2 – CAPA Tracking Log

SOP S-1013 UHL Serious Breaches V7 March 2018

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 – V7 March 2018

SOP S-1013 Appendix 2 Template file note V7 March 2018

SOP S-1013 Appendix 3 Protocol Deviation Tracking Log V7 March 2018

SOP S-1014 UHL Sponsor Green Light Process for research sponsored by UHL V10 March 2018

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

SOP S-1015 UHL Essential Documents V8 March 2018

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 UHL Appendix 1 TMF ISF Contents CTIMP V8 March 2018

SOP S-1015 UHL Appendix 2 TMF ISF Contents non CTIMP V8 March 2018

SOP S-1015 UHL Appendix 3 Version Control Doc V8 March 2018

SOP S-1015 UHL Appendix 4 File retention recommendations V8 March 2018

SOP S-1016 UHL Procedure in event of non compliance V6 March

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).

SOP S-1017 UHL Green Light Process for Amendments V6 March 18

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 UHL Appendix 1 V6 March 2018

SOP S-1017 UHL Appendix 2 V6 March 2018

SOP S-1017 UHL Appendix 3 V6 March 2018

SOP S-1017 UHL Appendix 4 V6 March 2018

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

This SOP details the steps required when Processing and Reporting SAE’s, SADEs and USADEs for Medical Device Studies.

SOP S-1038 SOP Processing and Reporting SAEs, SADEs and USADEs for Medical Device Studies

SOP S-1038 Appendix 1 Event Categorisation Flow Chart

SOP S-1038 Appendix 2 Adverse event Adverse Effect record

SOP S-1038 Appendix 3 Serious Adverse Event Report Form C

SOP S-1038 Appendix 4 Multicentre line listing

SOP S-1038 Appendix 5 MHRA reporting timelines table

SOP S-1038 Appendix 6 UHL Medical Device Process Flowchart

SOP S-1038 Appendix 7 Template SAE SADE Follow Up Information Request Email

This SOP details the steps required when conducting sample management for research studies.

SOP S-1039 Sample management for research studies sponsored by UHL

SOP S-1039 Appendix 1a FRIDGE Temperature Log

SOP S-1039 Appendix 1b FREEZER Temperature Log

SOP S- 1039 Appendix 1c NITROGEN Log

SOP S- 1039 Appendix 2 Sample Tracking Log

SOP S-1039 Appendix 3 Sample End of Study Sponsor Form

SOP S- Appendix 4 Shipping Instructions for Biological Samples

SOP S-1039 Appendix 5 Human Tissue Disposal Form