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
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
SOP069 Code Breaking in Clinical Trials
SOP065 Risk Adapted Approach to Management of Investigational Clinical Trials PTUC SOP065
SOP055 Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs PTUC SOP055
SOP052 Dealing with Misconduct and Fraud Good Research Practice R&D SOP052
SOP049 GCP Training for Research Staff PTUC SOP049
SOP048 Royal Papworth Sponsorship of Research Studies PTUC SOP048
SOP041 File Notes PTUC SOP041
SOP040 Management of External Research Staff - Research Passport Scheme R&D SOP040
SOP037 Amendments to Research Studies PTUC SOP037
SOP035 Using the Local Portfolio Management System (EDGE) R&D SOP035
SOP031 Patient Recruitment R&D SOP031
SOP029 Management of R&D Freezers R&D SOP029
SOP025 Assessment and Registration of Trust Risk Rating for Research Studies R&D SOP025
SOP023 Financial Procedures for Research Projects PTUC SOP023