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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
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
Ethics Approval of Research Studies(SOP 005).pdf PTUC SOP005
GD027 User guide to signing off SOPs on OpenClinca v5.0.pdf GD027 User Guide to Signing off SOPs on OpenClinica
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
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
Amendments to Research Studies (SOP 037).pdf PTUC SOP037
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
Project Management of Research Studies (SOP 009) PTUC SOP009
Financial Procedures for Research Projects (SOP 023).pdf PTUC SOP023
Archiving of Research Studies (SOP 011).pdf PTUC SOP011
Data Management Overview (SOP 077).pdf PTUC SOP077
Randomisation of Papworth Sponsored Clinical Trials (SOP 018).pdf PTUC SOP018
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
Informed Consent for Research Studies (SOP 003).pdf R&D SOP003
Protocol Non Compliance (SOP 050).pdf SOP050 SOP050
Protocol Non Compliance (SOP 050).pdf PTUC SOP050
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