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
Clinical Research Quality Manual
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
TEMP035 - Template TMG Terms of Reference
TEMP036 - Template TSC Terms of Reference
TEMP037 - Template IDSMC Charter
Quality Assurance SOPs
SOP001 - Production and Control SOP Production and Control of Standard Operating Procedures
SOP002 - Preparing and Hosting External Inspections
SOP024 - Quality Assurance
SOP025 - Sponsor Audit
SOP029 - Organisational Oversight of Clinical Trials of Investigational Medicinal Products (CTIMPs)
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