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:

 

 

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
Subcontracting of Research Activities (SOP 066).pdf PTUC SOP066
Gaining Regulatory Approval from the MHRA (SOP 014).pdf PTUC SOP014
Research Protocol Design (SOP 019).pdf PTUC SOP019
Intellectual Property Policy and SOP.pdf R&D
Patient Information Sheet & Consent Form Implementation and Development to the Research Team (SOP 020).pdf PTUC SOP020
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
Standard Operating Procedures (SOPs) Production, approval and review (001).pdf R&D SOP001
Urgent Safety Measures (SOP 071).pdf PTUC SOP071
Royal Papworth Sponsorship of Research Studies (SOP048).pdf PTUC SOP048
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
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