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 of the Policies and SOPs below, please contact:
- Karen Wilding
Senior Clinical Research Governance Manager
Email: sponsor@liverpool.ac.uk - Policies
- POL001 - Sponsorship of Research - Statement of Policy
- POL002 - Clinical Trials of Investigational Medicinal Products Sponsored by the University - Statement of Policy
- POL003 - Policy for the Management of Laboratory Endpoints in Clinical Trials at the University Of Liverpool
- QM001 - Clinical Research Quality Manual.
- Sponsorship Application and Approval SOPs
- SOP003 - Non CTU CTIMPs
- SOP004 - Sponsorship Application and Approval Processes
- SOP006 - Roles and Responsibilities for University of Liverpool Sponsored Research
- SOP012 - Requirements for Training for University Sponsored Research
- TEM019 - Training Log Template
- SOP013 - Completing an IRAS Application for Non-CTIMP Research
- SOP016 - Production and Management of Contracts for University Sponsored Clinical Research Activity
- SOP030 - Requirements for Insurance for University Sponsored research
- SOP031 - Completing an IRAS Application for CTIMPs
- SOP032 - Breaches of Clinical Research Governance procedures.
Study Management SOPs
- SOP007 - Safety Reporting for University of Liverpool Sponsored Research
- SOP005 - Maintaining a Study Master File for University Sponsored Clinical Research
- FORM015 - Example Checklist for Study Master File Contents
- SOP010 - Risk Assessment of Clinical Trials
- TEM005 - Clinical Trial Risk Assessment Template
- SOP011 - Monitoring of University Sponsored CTIMPs
- TEM024 - Clinical Trials Monitoring Plan Template
- SOP015 - Maintaining a Trial Master File for Clinical Trials of Investigational Medicinal Products (CTIMP) studies
- TEM023 - Template Checklist for Trial Master File Contents
- SOP017 - Identification and Notification of Serious Breaches
- FORM001 - Serious Breach Reporting Proforma
- SOP018 - Procedure for the Submission of Amendments
- SOP020 - Archiving of Essential Documents for University Sponsored Studies
- SOP021 - End of Study Procedures for University of Liverpool Sponsored Studies
- SOP023 - Oversight Committees for University sponsored CTIMPs