All research activity at Royal Papworth Hospital is conducted in accordance with Trust approved Standard Operating Procedures (SOPs) which are available to view by clicking on the individual titles of the SOPs in the list below.

Please click on the image below to view the routemap of SOPs used for clinical trials.

 

SOP routemap.png

 


The SOP Committee meets regularly to design and review the SOPs. For more information please email Vikki Hughes
 
Please note that forms, guidelines, templates and information sheets are available on the guidance documents, templates and forms page.

 

PTUC SOP's

The standard operating procedures relating to PTUC can be found below by searching for PTUC.  They will have PTUC in the 'Tags' column.

The following SOPs apply to both PTUC and R&D:

SOP 001 Production Approval and Review of SOPs

SOP 002 Training Records for Research Active Staff

New SOP's for Review:

SOP015 Location Selection and Initiation

SOP063 R&D Internal Good Clinical Practice (GCP) Audit

SOP067 Tissue Bank Deposits and Withdrawals

Title Tags Description
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
SOP063 Research and Development Internal Good Clinical Practice (GCP) Audit PTUC SOP063
Email Correspondence Study Related (SOP 064).pdf PTUC SOP064
SOP065 Risk Adapted Approach to Management of Investigational Clinical Trials PTUC SOP065
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
SOP067 Tissue Bank (Deposits and Withdrawals) R&D SOP067
SOP070 Expedited Trust Approval of Urgent Public Health Research Studies PTUC SOP070
SOP071 Urgent Safety Measures PTUC SOP071
SOP072 Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability PTUC SOP072
SOP073 Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling PTUC SOP073
SOP074 Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs R&D SOP074
SOP075 Quarantine of IMP's (Investigational Medicinal Products) PTUC SOP075
SOP076 Transport, Storage and Environmental Monitoring of IMP's R&D SOP076
Data Management Overview (SOP 077).pdf PTUC SOP077
Data Management Plan (SOP078).pdf PTUC SOP078
SOP079 Reference Safety Information (RSI) PTUC SOP079
SOP080 Study Data - Collection and Entry PTUC SOP080
SOP081 Destruction of Waste IMP (Investigational Medicinal Product) R&D SOP081
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
SOP084 Direct to Patient Delivery of IMP R&D SOP084