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:

 

 

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
Code Breaking Unblinding of Clinical Trials Training and Procedure Testing (SOP 069).pdf PTUC SOP069
Trial Closure and End of Trial Reporting (SOP 021).pdf PTUC SOP021
Email Correspondence Study Related (SOP 064).pdf PTUC SOP064
SOP085 Monitoring Research Studies - External Monitors and Remote Monitoring.pdf R&D SOP085
Data Management Overview (SOP 077).pdf PTUC SOP077
Protocol Non Compliance (SOP 050).pdf PTUC SOP050
Randomisation of Papworth Sponsored Clinical Trials (SOP 018).pdf PTUC SOP018
SOP 092 - Research Account Management - V1.0 Final.pdf
Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (SOP 055).pdf PTUC SOP055
SOP_092_-_Research_Account_Management_-_Final..docx.pdf SOP092 Research Account Management
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065).pdf PTUC SOP065
Patient Recruitment (SOP031).pdf R&D SOP031
SOP031 Patient Recruitment version 5.0.pdf Patient Recruitment Patient Recruitment
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf PTUC SOP073
Change of Investigator (SOP 038).pdf PTUC SOP038
Financial Procedures for Research Projects (SOP 023).pdf PTUC SOP023
Informed Consent for Research Studies (SOP 003).pdf R&D SOP003
Statistical Input into Clinical Trials (SOP 017).pdf PTUC SOP017
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf PTUC SOP051
Version Control of Study Documentation (SOP 060).pdf PTUC SOP060