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SOP downloads – host

3The 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 Document  

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 & 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 & Production of Corrective & Preventative Action Plan (CAPA)

C-2015

Identifying & Reporting Deviations & Serious Breaches of GCP

C-2016

Management of Suspected Fraud & Misconduct

C-2017

Archiving of Essential Documents

C-2018

End of Study Reporting Requirements

C-2019

Obtaining Finance Approval

C-2021

Use & Completion of Edge

C-2022

UHL Pandemic Plan for Research

C-2023

UHL Confirmation of C&C for Hosted Research

C-2024

UHL Corporate R&I Process for Confirming C&C for Hosted Studies

C-2025

Priority & Expedited Capacity & Capability Assessment

C-2027

UHL Re-Opening Studies During Pandemic

C-2028

UHL Remote Monitoring

C-2029

GDPR & Privacy Requirements

C-2030

UHL Healthy Volunteers in Hosted Research

 C-2033

UHL Implementing PRES (Participants in Research Experience Survey)

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
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-2003: Principle Investigator Responsibilities Appendix 1 - Roles and Responsibilities of PI Agreement
Appendix 2 - Blank Host DOA and Signature Log

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 1a - ISF Non UKCA CE Marked Medical Device Studies
Appendix 2 – Investigator Site File Index for studies NOT involving Investigational Medicinal Products
Appendix 2a - ISF UKCA CE Marked Medical Device Studies
Appendix 3 - ISF Version Control Document

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-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

C-2021: SOP for Use and Completion of EDGE

Appendix 1 – Data Verification Exercise Report

C-2023: SOP for Confirmation of C&C for Hosted Research

Appendix 1 - Setting Up A New Study 
Appendix 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 Research

Appendix 1 - Additions for Every Study
Appendix 2 – Support Departments
Appendix 3 – Dates & Targets
Appendix 4 – Study Status Definitions

C-2027: SOP for Re-Opening Studies During Pandemic

Appendix 1 – Process for Consideration during Covid-19 Pandemic
Appendix 2 – Re-Opening Studies During Pandemic Flowchart

 C-2028: UHL Remote Monitoring

 Appendix 1 - Remote Monitoring Risk Assessment

C-2029: GDPR & Privacy Requirements

Appendix 1 – Compliance to GDPR & Privacy Flowchart

 C-2033: UHL Implementing PRES
(Trust Reference Pending)
Appendix 1 - Survey
Appendix 2 - Feedback QR