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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
Gaining Regulatory Approval from the MHRA (SOP 014).pdf PTUC SOP014
SOP037 Amendments to Research Studies PTUC SOP037
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
SOP 050 Protocol Non Compliance PTUC SOP050
Version Control of Study Documentation (SOP 060).pdf PTUC SOP060
SOP071 Urgent Safety Measures PTUC SOP071
SOP013 Trial Master File Creation and Maintenance PTUC SOP013
Trial Closure and End of Trial Reporting (SOP 021).pdf PTUC SOP021
SOP080 Study Data - Collection and Entry PTUC SOP080
SOP072 Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability PTUC SOP072
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
Statistical Input into Clinical Trials (SOP 017).pdf PTUC SOP017
SOP073 Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling PTUC SOP073
Site Recruitment and Initiation (SOP 015).pdf PTUC SOP015
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf PTUC SOP051
SOP079 Reference Safety Information (RSI) PTUC SOP079
SOP055 Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs PTUC SOP055
SOP065 Risk Adapted Approach to Management of Investigational Clinical Trials PTUC SOP065
Research Protocol Design (SOP 019).pdf PTUC SOP019
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