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:

SOP048 Royal Papworth Sponsorship of Research Studies

SOP083 Monitoring Research Studies - Specific Considerations for the Risk Adapted Monitoring of CTIMPs

SOP091 Maintaining the IMP Blinding for Clinical Trials

Title Tags Description
SOP088 Clinical Trial Participants and Pregnancy.pdf R&D SOP088
SOP087 Adverse Event Reporting for Device Trials R&D SOP087
SOP086 Electronic Signature.pdf R&D SOP086
SOP085 Monitoring Research Studies - External Monitors and Remote Monitoring.pdf R&D SOP085
SOP084 Direct to Patient Delivery of IMP R&D SOP084
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
SOP081 Destruction of Waste IMP (Investigational Medicinal Product) R&D SOP081
SOP080 Study Data - Collection and Entry PTUC SOP080
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Data Management Plan (SOP078).pdf PTUC SOP078
Data Management Overview (SOP 077).pdf PTUC SOP077
SOP076 Transport, Storage and Environmental Monitoring of IMP's R&D SOP076
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
SOP074 Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs R&D SOP074
SOP073 Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling PTUC SOP073
SOP072 Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability PTUC SOP072
SOP071 Urgent Safety Measures PTUC SOP071
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070).pdf PTUC SOP070
Code Breaking Unblinding of Clinical Trials Training and Procedure Testing (SOP 069).pdf PTUC SOP069
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067