Standard Operating Procedures (SOPs)

 

Please note that Forms (FRM), Guidelines (GDS) and Template (TPL) documents and information sheets e.g. Adverse Event Form, Template Protocol etc are available in Template Documents

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New SOPs for Review:

 

 

SOPs in Alphabetical Order are available HERE

 

SOP 001 Production and Review and approval of SOPs
SOP 002 Training Records for Research Active Staff
SOP 003 Informed Consent for Research Studies
SOP 005 Ethics Approval of Research Studies
SOP 009 Project Management of Papworth Sponsored Studies
SOP 011 Archiving of Research Studies
SOP 012 Adverse Event Reporting
SOP 013 Trial Master File and Site File Creation and Maintenance
SOP 014 Regulatory Approval from the MHRA
SOP 015 Site Recruitment and Initiation
SOP 016 Monitoring Research Studies
SOP 017 Statistical Input in Clinical Trials
SOP 018 Randomisation
SOP 019 Research Protocol Design
SOP 020 Patient Information Sheets and Consent Forms
SOP 021 Trial Closure and End of Trial Reporting
SOP 023 Financial Procedures for Research Studies
SOP 024 Contract Negotiation and Review
SOP 025 Assessment and Registration of Trust Risk Rating for Research Studies
SOP 029 Management of Research and Development Freezers
SOP 030 Roles and Responsibilities/Delegation Log
SOP 031 Patient Recruitment
SOP 034 Trust Approval and Research Governance
SOP 035 Research Database Application
SOP 037 Amendments to Research Studies
SOP 038 Change of Investigator
SOP 040 Management of External Staff - Research Passport Scheme
SOP 041 File Note
SOP 044 Emergency Trolley in CTBI
SOP 048 Papworth Sponsorship of Research Studies
SOP 049 GCP Training for Research Staff
SOP 050 Protocol Non-Compliance
SOP 051 Serious Breach of Protocol or GCP in CTIMPs
SOP 052 Misconduct and Fraud: Good Clinical Practice
SOP 055 Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials
SOP 060 Version Control of Study Documents
SOP 062 Preparation of Development Safety Update
SOP 063 Research and Development: Internal Good Clinical practice (GCP) Audit
SOP 064 Study Related Email Correspondence
SOP 065 Risk Adapted Approach to the Management of Clinical Trials of Investigational Medicinal Products (IMPs)
SOP 066 Subcontracting of Research Activities
SOP 067 Tissue Bank (Deposits and Withdrawals)
SOP 069 Code Breaking/Unblinding of Clinical Trials, training and procedure testing
SOP 070 Expedited Trust Approval of Urgent Public Health Research Studies
SOP 071 Urgent Safety Measures
SOP 072 Supply of Clinical Trials Investigational Material Dispensing Returns and Accountability
SOP 073 Sourcing of Clinical Trial IMPs for Papworth Sponsored Trials
SOP 074 Handling of Drug Alerts and Recalls of IMPs or Other Trials Related Drugs
SOP 075 Quarantine of CTIMPs
SOP 076 Transport Storage and Environmetal Monitoring
SOP 077 Data Management Overview
SOP 079 Reference Safety Information (RSI)
SOP 080 Study Data - Collection and Entry

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