Below are the standard operating procedures relating to PTUC. All standard operating procedures can be viewed here.
Quality management systems
SOP001 - Production Approval and Review of SOPs
SOP002 - Training Records for Research Active Staff
SOP016 - Monitoring Research Studies
SOP049 - GCP Training for Research Staff
SOP063 - Research and Development: Internal Good Clinical Practice (GCP) Audit
SOP069 - Code Breaking/Unblinding of Clinical Trials, Training and Procedure Testing
All trials
SOP005 - Ethics Approval of Research Studies
SOP009 - Project Management of Research Studies
SOP011 - Archiving of Research Studies
SOP012 - Adverse Event Reporting
SOP013 - Trial Master File and Site File Creation and Maintenance
SOP014 - Gaining Regulatory Approval from the MHRA
SOP015 - Site Recruitment and Initiation for Papworth Sponsored Studies
SOP017 - Statistical Input into Clinical Trials
SOP018 - Randomisation of Research Studies
SOP019 - Research Protocol Design
SOP020 - Patient Information Sheets, Consent Forms: Development and Implementation
SOP021 - Trial Closure and End of Trial Reporting
SOP023 - Financial Procedures for Research Studies
SOP024 - Contract Negotiation and Review
SOP037 - Amendments to Research Studies
SOP048 - Papworth Sponsorship of Research Studies
SOP050 - Handling of Protocol Non Compliance
SOP051 - Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices
SOP060 - Version Control of Study Documents
SOP066 - Subcontracting of Research Activities
SOP070 - Expedited Trust Approval of Urgent Public Health Research Studies
SOP073 - Sourcing of Clinical Trial Investigational Medicinal Products for Papworth Sponsored Studies: Manufacturing, Assembly and Labelling
SOP075 - Quarantine of CTIMPs
SOP077 - Data Management Overview
CTIMPS
SOP062 - Preparation of Regulatory Progress Reports Incluidng Periodic Safety Reporting and Annual Reports
SOP064 - Email Correspondence: Study Related
SOP071 - Urgent Safety Measures
SOP072 - Supply of Clinical Trials Investigational Material (IMP's): Dispensing, Returns and Accountability
