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
sop-route-map updated 26.09.2019.pptx
SOP031 Patient Recruitment version 5.0.pdf Patient Recruitment Patient Recruitment
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
SOP084 Direct to Patient Delivery of IMP version 1.0 FINAL.pdf R&D SOP084
SOP085 Monitoring Research Studies - External Monitors and Remote Monitoring.pdf R&D SOP085
SOP086 Electronic Signature.pdf R&D SOP086
SOP088 Clinical Trial Participants and Pregnancy.pdf R&D SOP088
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf PTUC SOP073
Standard Operating Procedures (SOPs) Production, approval and review (001).pdf R&D SOP001
Statistical Input into Clinical Trials (SOP 017).pdf PTUC SOP017
Study Data - Collection and Entry (SOP080).pdf PTUC SOP080
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
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Training Records for Research Active Staff (SOP 002).pdf R&D SOP002
Transport, Storage and Enviromental Monitoring of IMP's (SOP 076).pdf R&D SOP076
Trial Closure and End of Trial Reporting (SOP 021).pdf PTUC SOP021
Trial Master File Creation and Maintenance (SOP013).pdf PTUC SOP013
Trust Confirmation of Capacity and Capability to Conduct Research Studies (SOP034).pdf R&D SOP034