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


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
Research and Development Internal Good Clinical Practice (GCP) Audit (SOP 063).pdf PTUC SOP063
Reference Safety Information (RSI) (SOP 079).pdf PTUC SOP079
Randomisation of Papworth Sponsored Clinical Trials (SOP 018).pdf PTUC SOP018
Protocol Non Compliance (SOP 050).pdf PTUC SOP050
Project Management of Research Studies (SOP 009) PTUC SOP009
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf PTUC SOP062
Patient Information Sheet & Consent Form Implementation and Development to the Research Team (SOP 020).pdf PTUC SOP020
Monitoring Research Studies (SOP 016).pdf PTUC SOP016
Management of External Research Staff - Research Passport Scheme (SOP 040).pdf R&D SOP040
Informed Consent for Research Studies (SOP 003).pdf R&D SOP003
Handling of Drug Alerts and Recalls of Investigational Medicinal Products (IMPs) or other trial related drugs (SOP074).pdf R&D SOP074
GCP Training for Research Staff (SOP 049).pdf PTUC SOP049
Gaining Regulatory Approval from the MHRA (SOP 014).pdf PTUC SOP014
Financial Procedures for Research Projects (SOP 023).pdf PTUC SOP023
File Notes (SOP 041).pdf PTUC SOP041
Expedited Trust Approval of Urgent Public Health Research Studies (SOP 070).pdf PTUC SOP070
Ethics Approval of Research Studies(SOP 005).pdf PTUC SOP005
Email Correspondence Study Related (SOP 064).pdf PTUC SOP064
DN171 Intellectual Property Policy and SOP.pdf R&D DN171
Destruction of Waste IMP (Investigational Medicinal Product) (SOP081).pdf R&D SOP081