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:

SOP009 – Set up & project management of research studies

SOP011 – Archiving of research studies

SOP050 – Handling of protocol non-compliance

SOP079 – Reference safety information

SOP097 – Sample transport

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
Urgent Safety Measures (SOP 071).pdf PTUC SOP071
Version Control of Study Documentation (SOP 060).pdf PTUC SOP060
Protocol Non Compliance (SOP 050).pdf PTUC SOP050
SOP075 Quarantine of IMP's (Investigational Medicinal Products).pdf PTUC SOP075
Assessment and Registration of Trust Risk Rating for Research Studies (SOP 025).pdf R&D SOP025
Dealing with Misconduct and Fraud Good Research Practice (SOP052).pdf R&D SOP052
Destruction of Waste IMP (Investigational Medicinal Product) (SOP081).pdf R&D SOP081
Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs (SOP074).pdf R&D SOP074
Informed Consent for Research Studies (SOP 003).pdf R&D SOP003
DN171 Intellectual Property Policy and SOP.pdf R&D DN171
Management of External Research Staff - Research Passport Scheme (SOP 040).pdf R&D SOP040
Standard Operating Procedures (SOPs) Production, approval and review (001).pdf R&D SOP001
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
Trust Confirmation of Capacity and Capability to Conduct Research Studies (SOP034).pdf R&D SOP034
Using the Research Governance Database (SOP035).pdf R&D SOP035
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
SOP084 Direct to Patient Delivery of IMP R&D SOP084
SOP085 Monitoring Research Studies - External Monitors and Remote Monitoring.pdf R&D SOP085