| 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
|
