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 085 Monitoring Research Studies External and Remote Monitoring

SOP 014 Gaining Regulatory Approval From the MHRA

SOP 009 Project Management of Research Studies 

SOP 062 Preparation of Regulatory Progress Reports

 

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
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
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065).pdf PTUC SOP065
Patient Recruitment (SOP031).pdf R&D SOP031
Adverse Event Reporting (SOP 012).pdf PTUC SOP012
SOP082 Returns of IMP to Pharmacy.pdf R&D SOP082
Code Breaking Unblinding of Clinical Trials Training and Procedure Testing (SOP 069).pdf PTUC SOP069
Change of Investigator (SOP 038).pdf PTUC SOP038
Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (SOP 055).pdf PTUC SOP055
Standard Operating Procedures (SOPs) Production, approval and review (001).pdf R&D SOP001
Email Correspondence Study Related (SOP 064).pdf PTUC SOP064
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Urgent Safety Measures (SOP 071).pdf PTUC SOP071
Training Records for Research Active Staff (SOP 002).pdf R&D SOP002
Management of External Research Staff - Research Passport Scheme (SOP 040).pdf R&D SOP040
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
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