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 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.

C-2001: SOP for Informed Consent

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

This SOP has some appendices which are:

SOP C-2001 Appendix 1 – Delegation of Authority and Signature Log

SOP C-2001 Appendix 2 – Assent Signature Log

C-2002: SOP for Processing and Reporting of SAEs, SARs and SUSARs

This SOP describes the process for identifying, documenting and reporting all Adverse Events and Reactions where Leicester’s Hospitals is the HOST/Research site.

This SOP has some appendices which are:

SOP C-2002 Appendix 1 – Pregnancy Reporting Form

SOP C-2002 Appendix 2 – CTIMP Line Listing

SOP C-2002 Appendix 3 – Non-CTIMP Line Listing

C-2003: SOP for Principal Investigator Responsibilities

This SOP describes the role and responsibilities of the Principal Investigator for research HOSTED by Leicester’s Hospitals or where Leicester’s Hospitals is the Research site.

C-2004: SOP for Management (Monitoring) of Research Hosted by Leicester’s Hospitals

This SOP describes the procedures for management of a study HOSTED by/or where Leicester’s Hospitals is the research site.

C-2005: SOP for Training for Staff Engaged in Research Hosted by Leicester’s Hospitals

This SOP describes the minimum training requirements for personnel involved in  research HOSTED by/or where Leicester’s Hospitals is the research site.

C-2006: SOP for Expression of Interest, Feasibility and Site Selection Process

This SOP describes the requirements to provide assurance that a robust process has been followed when responding to Expression of Interest (EOI), Feasibility or Site selection requests for any research conducted within a Clinical Management Group (CMG), Clinical Specialty or Corporate Directorate at Leicester’s Hospitals.

C-2006a: SOP for Dealing with Expressions of Interest, Feasibility, Capability and Site Selection

This SOP describes the requirements to provide assurance that a robust review has been conducted within an individual Specialty area, Clinical Management Group (CMG) or Directorate and appropriate registration on the EDGE database is confirmed when responding to Expressions of Interest (EOI), Feasibilities, Capabilities or Site selection requests for research within Leicester’s Hospitals.

C-2007: SOP for the Operational Capability Assessment Process

This SOP describes the process required to provide adequate assurance that an individual specialty within a Clinical Management Group (CMG) can deliver a research study in accordance with the approved protocol and appropriate contract or agreement/Statement of Activity.

C-2007a: SOP for the Operational Capability Assessment Process (arrange study) within a Specialty or Clinical Management Group

This SOP describes the process required to make necessary arrangements within individual specialties or Clinical Management Groups (CMGs) to deliver a research study in accordance with the approved protocol and appropriate contract or agreement/Statement of Activity, where feasibility/site selection has been conducted.

This SOP has an appendix which is:

SOP C-2007a Appendix 1 – Operational Capability Assessment (Arrange Study)

C-2008: SOP for the Process of Gaining Trust Authorisation for Research HOSTED by Leicester’s Hospitals

This SOP describes the process at Leicester’s Hospitals for giving ‘Authorisation’ for research activity when Leicester’s Hospitals are the HOST organisation or Research Site.

C-2009: SOP for Management of Essential Documents and Study Filing for Research HOSTED by Leicester’s Hospitals

This SOP describes the creation of an audit trail through the retention of essential documents in the Investigator Site file (ISF) for all research HOSTED by Leicester’s Hospitals.

This SOP has some appendices which are:

SOP C-2009 Appendix 1 – Investigator Site File Index for Clinical Trials of Investigational Medicinal Products

SOP C-2009 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

This SOP describes the process for approving studies involving the use of genetically modified material and/or gene therapy in Leicester’s Hospitals.

This SOP has some appendices which are:

SOP C-2010 Appendix 1 – GM Application Check list

SOP C-2010 Appendix 2 – GM Committee Application Review

SOP C-2010 Appendix 3 – GM Committee Application Review Comments

C-2011: SOP for Authorisation of Amendments or Additions to Documents for Studies already Authorised

This SOP details the procedures for managing amendments in research when Leicester’s Hospitals are the HOST organisation or Research Site.

C-2012: SOP for Management of Contracts for Research Hosted by Leicester’s Hospitals

This SOP describes the procedures used by Leicester’s Hospitals when providing and managing agreements with third parties.

This SOP has an appendix which is:

SOP C-2012 Appendix 1 – Process Flow Chart

C-2013: SOP for the Procedure in the Event of Non-Compliance

This SOP describes the process of responding to any form of non-compliance identified in Research Hosted by Leicester’s Hospitals.

C-2014: SOP for the Management and Production of Corrective and Preventative Action Plan (CAPA)

This SOP describes the process to be followed when breaches/deviations of Research Protocol, Good Clinical Practice in Research (ICH GCP), Sponsor/Host Standard Operating Procedures or Agreements have been identified.

This SOP has an appendix which is:

SOP C-2014 Appendix 1 – CAPA Template

C-2015: SOP for Identifying and Reporting Deviations and Serious Breaches of GCP

This SOP describes the process for the identification and reporting of serious breaches of GCP and/or the approved study protocol in all Research Hosted by Leicester’s Hospitals.

This SOP has an appendix which is:

SOP C-2015 Appendix 1 – Site File Note Template

C-2016: SOP for the Management of Suspected Fraud and Misconduct

This SOP describes the procedures required for management of suspected fraud and misconduct in Research Hosted by Leicester’s Hospitals.

This SOP has some appendices which are:

SOP C-2016 Appendix 1 – Suspected Fraud or Misconduct Initial Investigation Template

SOP C-2016 Appendix 2 – Suspected Fraud or Misconduct Interview Template

SOP C-2016 Appendix 3 – Evidence Listing Template

C-2017: SOP for Archiving of Essential Documents

This SOP describes the requirements for archiving of all Research Hosted by Leicester’s Hospitals.

C-2018: SOP for End of Study Reporting Requirements

This SOP describes the processes required at the end of a research study Hosted by Leicester’s Hospitals.

C-2019: SOP for Obtaining Finance Approval

This SOP describes the requirements for obtaining finance approval for Research Hosted by Leicester’s Hospitals.