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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.

New SOP's for Review:

SOP 037 Amendments to Research Studies

SOP 038 Change of Investigator

SOP 073 Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies

 

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

 

 

 

 

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
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065).pdf 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
Urgent Safety Measures (SOP 071).pdf PTUC SOP071
Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability (SOP 072).pdf PTUC SOP072
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf PTUC SOP073
Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs (SOP074).pdf R&D SOP074
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
Transport, Storage and Enviromental Monitoring of IMP's (SOP 076).pdf R&D SOP076
Data Management Overview (SOP 077).pdf PTUC SOP077
Data Management Plan (SOP078).pdf PTUC SOP078
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Study Data - Collection and Entry (SOP080).pdf PTUC SOP080
Destruction of Waste IMP (Investigational Medicinal Product) (SOP081).pdf R&D SOP081
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
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