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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
Adverse Event Reporting (SOP 012).pdf PTUC SOP012
Assessment and Registration of Trust Risk Rating for Research Studies (SOP 025).pdf R&D SOP025
SOP099 HLRI CRF Medical cover v2 .pdf SOP099 HLRI CFR Medical Cover for Research Studies SOP099 HLRI CRF Medical Cover for Research Studies
SOP097 Sample Transport v1.0.pdf SOP097 Sample Transport Sample Transport SOP
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
Project Management of Research Studies (SOP 009) PTUC SOP009
Monitoring Research Studies (SOP 016).pdf PTUC SOP016
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
Archiving of Research Studies (SOP 011).pdf PTUC SOP011
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
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
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
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