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Policies and Standard Operating Procedures

You can find Policies and Standard Operating Procedures below.

As a sponsor of research, the University has specific responsibilities under the UK Policy Framework for Health and Social Care Research and the Medicines for Human Use (Clinical Trials) Regulations 2004 (the Regulations). The University has developed Policies and Standard Operating Procedures (SOPs) to provide guidance to researchers and to ensure that these responsibilities are met.

They must be adhered to for all University-sponsored studies, and it is a condition of sponsorship that they are read and understood.

For further training on any Policies and SOPs below, please email Karen Wilding, Senior Clinical Research Governance Manager, at sponsor@liverpool.ac.uk.

  • SOP001 - Production and Control SOP Production and Control of Standard Operating Procedures (PDF, 140KB)
  • SOP002- Preparing and Hosting External Inspections (PDF, 120KB)
  • SOP003 - Non-CTU CTIMPs (PDF, 147KB)
  • SOP004 - Sponsorship Application and Approval Processes (PDF, 163KB)
  • SOP005 - Maintaining a Study Master File for University Sponsored Clinical Research (PDF, 106KB
    • FORM015 - Example Checklist for Study Master File Contents (DOCX, 61KB)
  • SOP006 - Roles and Responsibilities for University of Liverpool Sponsored Research (PDF, 133KB)
  • SOP007 - Safety Reporting for University of Liverpool Sponsored Research (PDF, 160KB)
  • SOP010 - Risk Assessment of Clinical Trials (PDF, 107KB) 
    • TEM005 - Clinical Trial Risk Assessment Template (DOCX, 83KB)
  • SOP011 - Monitoring of University Sponsored CTIMPs (PDF, 100KB)
    • TEM024 - Clinical Trials Monitoring Plan Template (DOCX, 64KB)
  • SOP012 - Requirements for Training for University Sponsored Research (PDF, 115KB)
    • TEM019 - Training Log Template (DOCX, 44KB)
  • SOP013 - Completing an IRAS Application for Non-CTIMP Research (PDF, 127KB)
  • SOP015 - Maintaining a Trial Master File for Clinical Trials of Investigational Medicinal Products (CTIMP) studies (PDF, 17MB)
    • TEM023 - Template Checklist for Trial Master File Contents (DOCX, 37KB)
  • SOP016 - Production and Management of Contracts for University Sponsored Clinical Research Activity (PDF, 1.7MB)
  • SOP017 - Identification and Notification of Serious Breaches (PDF, 130KB)
    • FORM001 - Serious Breach Reporting Proforma (DOCX, 66KB)
  • SOP018 - Procedure for the Submission of Amendments (PDF, 138KB)
  • SOP020 - Archiving of Essential Documents for University Sponsored Studies (PDF, 4MB)
  • SOP021 - End of Study Procedures for University of Liverpool Sponsored Studies (PDF, 2.3MB)
  • SOP023 - Oversight Committees for University sponsored CTIMPs (PDF, 1.7MB)
    • TEMP035 - Template TMG Terms of Reference (DOCX, 87KB)
    • TEMP036 - Template TSC Terms of Reference (DOCX, 93KB)
    • TEMP037 - Template IDSMC Charter (DOCX, 96KB)
  • SOP024 - Quality Assurance (PDF, 128KB)
  • SOP025 - Sponsor Audit (PDF, 136KB)
  • SOP029 - Organisational Oversight of Clinical Trials of Investigational Medicinal Products (CTIMPs)
  • SOP030 - Requirements for Insurance for University Sponsored research (PDF, 2.1MB)
  • SOP031 - Completing an IRAS Application for CTIMPs (PDF, 326KB)
  • SOP032 - Breaches of Clinical Research Governance procedures. (PDF, 0.5MB)
  • SOP035 - Compliance with the NHS Data Security and Protection Toolkit (PDF, 162KB)