Standard Operating Procedures (SOPs) - Hosts:

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-2009:

Management of Essential Documents & Study Filing for Research Hosted by Leicester’s Hospitals

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-2022:

UHL Pandemic Plan for Research

J-5004:

UHL Confirmation of C&C for Hosted Research

C-2025:

Priority & Expedited Capacity & Capability Assessment

C-2027:

UHL Re-Opening Studies During Pandemic

C-2028:

UHL Remote Monitoring

C-2030:

UHL Healthy Volunteers in Hosted Research

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-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-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-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