SOP downloads – host

The documents on this page are for studies where Leicester’s Hospitals is the HOST/Research SITE.

Index of Standard Operating Procedures for all research HOSTED by the University Hospitals of Leicester or where the University Hospitals of Leicester is a SITE

SOP Reference NumberSOP Document  
S-1000Writing Standard Operating Procedures for Research and Development
C-2001Informed Consent
C-2002Processing and Reporting of SAEs, SARs and SUSARs
C-2003Principal Investigator Responsibilities
C-2005Training for Staff Engaged in Research Hosted by Leicester’s Hospitals
C-2006Expression of Interest, Feasibility and Site Selection Process
C-2006aDealing with Expressions of Interest, Feasibility, Capability and Site Selection
C-2007Operational Capability Assessment Process
C-2008Process of Gaining Trust Authorisation for Research Hosted by Leicester’s Hospitals
C-2009Management of Essential Documents & Study Filing for Research Hosted by Leicester’s Hospitals
C-2010Pre-Approval of Studies Involving Genetically Modified Material and/or Gene Therapy
C-2011Authorisation of Amendments or Additions to Documents for Studies Already Authorised
C-2012Management of Contracts for Research Hosted by Leicester’s Hospitals
C-2013Procedure in the Event of Non-Compliance
C-2014Management & Production of Corrective & Preventative Action Plan (CAPA)
C-2015Identifying & Reporting Deviations & Serious Breaches of GCP
C-2016Management of Suspected Fraud & Misconduct
C-2017Archiving of Essential Documents
C-2018End of Study Reporting Requirements
C-2019Obtaining Finance Approval
C-2021Use & Completion of Edge
C-2022UHL Pandemic Plan for Research
C-2023UHL Confirmation of C&C for Hosted Research
C-2024UHL Corporate R&I Process for Confirming C&C for Hosted Studies
C-2025Priority & Expedited Capacity & Capability Assessment
C-2027UHL Re-Opening Studies During Pandemic
C-2028UHL Remote Monitoring
C-2030UHL Healthy Volunteers in Hosted Research
SOP Reference Number & TitleAppendix Title
C-2001: SOP for Informed ConsentAppendix 1 – Delegation of Authority and Signature Log
C-2002: SOP for Processing and Reporting of SAEs, SARs and SUSARsAppendix 1 – Pregnancy Reporting Form
Appendix 2 – CTIMP Line Listing
Appendix 3 – Non-CTIMP Line Listing
Appendix 4 – SAE Line Listing Reminder Email
Appendix 5 – SAE Line Listing Second Reminder Email
Appendix 6 – SAE Line Listing Final Reminder Email
Appendix 7 – SAE Line Listing Request for Further Information
Appendix 8 – Acknowledgement of SAE Line Listing Email
Appendix 9 – SAE Line Listing Workflow
C-2009: SOP for Management of Essential Documents and Study Filing for Research HOSTED by Leicester’s HospitalsAppendix 1 – Investigator Site File Index for Clinical Trials of Investigational Medicinal Products
Appendix 2 – Investigator Site File Index for studies NOT involving Investigational Medicinal Products
C-2010: SOP for the Pre-Approval of Studies Involving Genetically Modified Material and/or Gene TherapyAppendix 1 – GM Application Check list
Appendix 2 – GM Committee Application Review
Appendix 3 – GM Committee Application Review Comments
C-2012: SOP for Management of Contracts for Research Hosted by Leicester’s HospitalsAppendix 1 – Process Flow Chart
C-2014: Management and Production of Corrective and Preventative Action Plan (CAPA)Appendix 1 – CAPA Template
C-2015: SOP for Identifying and Reporting Deviations and Serious Breaches of GCPAppendix 1 – Site File Note Template
C-2016: SOP for the Management of Suspected Fraud and MisconductAppendix 1 – Suspected Fraud or Misconduct Initial Investigation Template
Appendix 2 – Suspected Fraud or Misconduct Interview Template
Appendix 3 – Evidence Listing Template
C-2021: SOP for Use and Completion of EDGEAppendix 1 – Data Verification Exercise Report

C-2023: SOP for Confirmation of C&C for Hosted ResearchAppendix 2 – Feasibility Assessment Form
Appendix 3 – EDGE Admin. Declaration of Understanding
Appendix 4 – List of Attributes-Responsibilties
Appendix 5 – Workflows-Responsibilties
Appendix 6 – Process Flow Chart
C-2024: SOP for Corporate R&I Process for Confirming C&C for Hosted ResearchAppendix 2 – Support Departments
Appendix 3 – Dates & Targets
Appendix 4 – Study Status Definitions
C-2027: SOP for Re-Opening Studies During PandemicAppendix 1 – Process for Consideration during Covid-19 Pandemic
Appendix 2 – Re-Opening Studies During Pandemic Flowchart