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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:

SOP034 Trust Confirmation of Capacity & Capability & Sponsor Green Light Notification to Conduct Research Studies

SOP124 Biological Sample Handling

SOP029 Management of R&D Freezers

SOP087 Adverse Event Reporting for Device Trials

SOP013 Trial Master File (TMF) Creation and Maintenance

SOP020 Participant Information Sheets and Consent Forms: Development and Implementation

Title Tags Description
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf PTUC SOP051
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
SOP072 Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability PTUC SOP072
SOP080 Study Data - Collection and Entry PTUC SOP080
SOP012 Adverse Event Reporting PTUC SOP012
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
SOP055 Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs PTUC SOP055
Trial Closure and End of Trial Reporting (SOP 021).pdf PTUC SOP021
SOP013 Trial Master File Creation and Maintenance PTUC SOP013
Royal Papworth Sponsorship of Research Studies (SOP048).pdf PTUC SOP048
SOP071 Urgent Safety Measures PTUC SOP071
Research Protocol Design (SOP 019).pdf PTUC SOP019
Version Control of Study Documentation (SOP 060).pdf PTUC SOP060
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
SOP 050 Protocol Non Compliance PTUC SOP050
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
Project Management of Research Studies (SOP 009) PTUC SOP009
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
SOP020 Patient Information Sheet & Consent Form Implementation and Development PTUC SOP020
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