PTUC standard operating procedures

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

SOP014 - Gaining Regulatory Approval from the MHRA

SOP062 - Preparation of Regulatory Progress Reports Incluidng Periodic Safety Reporting and Annual Reports

SOP064 - Email Correspondence: Study Related

SOP069 - Code Breaking/Unblinding of Clinical Trials, Training and Procedure Testing

SOP071 - Urgent Safety Measures

SOP072 - Supply of Clinical Trials Investigational Material (IMP's): Dispensing, Returns and Accountability