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
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070).pdf PTUC SOP070
Supply of Clinical Trials Investigational Medicinal Products (IMP) Dispensing Returns and Accountability (SOP 072).pdf PTUC SOP072
File Notes (SOP 041).pdf PTUC SOP041
Trust Confirmation of Capacity and Capability to Conduct Research Studies (SOP034).pdf R&D SOP034
Tissue Bank (Deposits and Withdrawals) (SOP 067).pdf R&D SOP067
Trial Master File Creation and Maintenance (SOP013).pdf PTUC SOP013
GCP Training for Research Staff (SOP 049).pdf PTUC SOP049
Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs (SOP074).pdf R&D SOP074
Transport, Storage and Enviromental Monitoring of IMP's (SOP 076).pdf R&D SOP076
Using the Research Governance Database (SOP035).pdf R&D SOP035
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
Site Recruitment and Initiation (SOP 015).pdf PTUC SOP015
Contract Negotiation and Review (SOP 024).pdf PTUC SOP024
Destruction of Waste IMP (Investigational Medicinal Product) (SOP081).pdf R&D SOP081
Study Data - Collection and Entry (SOP080).pdf PTUC SOP080
Assessment and Registration of Trust Risk Rating for Research Studies (SOP 025).pdf R&D SOP025
SOP088 Clinical Trial Participants and Pregnancy.pdf R&D SOP088
SOP086 Electronic Signature.pdf R&D SOP086
Data Management Plan (SOP078).pdf PTUC SOP078
SOP084 Direct to Patient Delivery of IMP version 1.0 FINAL.pdf R&D SOP084