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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 find attached here a routemap which shows a timelime of SOPs used for clinical trials.


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:

SOP011 Archiving of Research Studies

SOP35 Using the Local Portfolio Management System

SOP041 File Notes

SOP082 Return of IMPS to Pharmacy

 

Title Tags Description
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf 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
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Code Breaking Unblinding of Clinical Trials Training and Procedure Testing (SOP 069).pdf PTUC SOP069
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070).pdf 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).pdf 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
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