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 025 Assessment & Registration of Trust Risk Rating for Research Studies

SOP 080 Study Data - Collection and Entry

SOP 081 Destruction of Waste IMP

SOP 024 Contract Negotiation and Review

SOP 016 Monitoring Research Studies

SOP 066 Subcontracting of Research Activities

 

 

 

 

Title Tags Description
SOP088 Clinical Trial Participants and Pregnancy.pdf R&D SOP088
SOP086 Electronic Signature.pdf R&D SOP086
SOP085 Monitoring Research Studies - External Monitors and Remote Monitoring.pdf R&D SOP085
SOP084 Direct to Patient Delivery of IMP version 1.0 FINAL.pdf R&D SOP084
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
Destruction of Waste IMP (Investigational Medicinal Product) (SOP081).pdf R&D SOP081
Study Data - Collection and Entry (SOP080).pdf PTUC SOP080
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Data Management Plan (SOP078).pdf PTUC SOP078
Data Management Overview (SOP 077).pdf PTUC SOP077
Transport, Storage and Enviromental Monitoring of IMP's (SOP 076).pdf R&D SOP076
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs (SOP074).pdf R&D SOP074
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf PTUC SOP073
Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability (SOP 072).pdf PTUC SOP072
Urgent Safety Measures (SOP 071).pdf PTUC SOP071
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070).pdf PTUC SOP070
Code Breaking Unblinding of Clinical Trials Training and Procedure Testing (SOP 069).pdf PTUC SOP069
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066