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 Number SOP Title
S-1000 Writing Standard Operating Procedures for Research and Development
C-2001 Informed Consent
C-2002 Processing and Reporting of SAEs, SARs and SUSARs
C-2003 Principal Investigator Responsibilities
   
C-2005 Training for Staff Engaged in Research Hosted by Leicester’s Hospitals
C-2006 Expression of Interest, Feasibility and Site Selection Process
C-2006a Dealing with Expressions of Interest, Feasibility, Capability and Site Selection
C-2007 Operational Capability Assessment Process
   
C-2008 Process of Gaining Trust Authorisation for Research HOSTED by Leicester’s Hospitals
C-2009 Management of Essential Documents and Study Filing for Research HOSTED by Leicester’s Hospitals
C-2010 Pre-Approval of Studies Involving Genetically Modified Material and/or Gene Therapy
C-2011 Authorisation of Amendments or Additions to Documents for Studies already Authorised
C-2012 Management of Contracts for Research Hosted by Leicester’s Hospitals
C-2013 Procedure in the Event of Non-Compliance
C-2014 Management and Production of Corrective and Preventative Action Plan (CAPA)
C-2015 Identifying and Reporting Deviations and Serious Breaches of GCP
C-2016 Management of Suspected Fraud and Misconduct
C-2017 Archiving of Essential Documents
C-2018 End of Study Reporting Requirements
C-2019 Obtaining Finance Approval
SOP Reference Number & Title Appendix Title    
C-2001: SOP for Informed Consent Appendix 1 – Delegation of Authority and Signature Log
C-2002: SOP for Processing and Reporting of SAEs, SARs and SUSARs Appendix 1 – Pregnancy Reporting Form
Appendix 2 – CTIMP Line Listing
Appendix 3 – Non-CTIMP Line Listing
   
C-2009: SOP for Management of Essential Documents and Study Filing for Research HOSTED by Leicester’s Hospitals Appendix 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 Therapy Appendix 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 Hospitals Appendix 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 GCP Appendix 1 – Site File Note Template
C-2016: SOP 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