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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
Gaining Regulatory Approval from the MHRA (SOP 014).pdf PTUC SOP014
Monitoring Research Studies (SOP 016).pdf PTUC SOP016
Royal Papworth Sponsorship of Research Studies (SOP048).pdf PTUC SOP048
Patient Information Sheet & Consent Form Implementation and Development to the Research Team (SOP 020).pdf PTUC SOP020
Project Management of Research Studies (SOP 009) PTUC SOP009
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
Randomisation of Papworth Sponsored Clinical Trials (SOP 018).pdf PTUC SOP018
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
Research Protocol Design (SOP 019).pdf PTUC SOP019
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065).pdf PTUC SOP065
Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (SOP 055).pdf PTUC SOP055
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf PTUC SOP051
Site Recruitment and Initiation (SOP 015).pdf PTUC SOP015
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf PTUC SOP073
Statistical Input into Clinical Trials (SOP 017).pdf PTUC SOP017
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability (SOP 072).pdf PTUC SOP072
Study Data - Collection and Entry (SOP080).pdf PTUC SOP080
Trial Closure and End of Trial Reporting (SOP 021).pdf PTUC SOP021
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