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.
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
New SOP's for Review:
SOP003 Obtaining Informed Consent for Research Studies
SOP025 Assessment & Registration of Trust Risk Rating for Research Studies
SOP060 Version Control of Study Documentation
SOP075 Quarantine of IMPs (Investigational Medicinal Products)
SOP085 Monitoring Research Studies - External Monitors & Remote Monitoring
SOP088 Clinical Trial Participants & Pregnancy
SOP124 Biological Sample Handling
| Title | Tags | Description |
|---|---|---|
| Statistical Input into Clinical Trials (SOP 017).pdf | PTUC | SOP017 |
| Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf | PTUC | SOP051 |
| 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 |
| Site Recruitment and Initiation (SOP 015).pdf | PTUC | SOP015 |
| Contract Negotiation and Review (SOP 024).pdf | PTUC | SOP024 |
| SOP086 Electronic Signature.pdf | R&D | SOP086 |
| Data Management Plan (SOP078).pdf | PTUC | SOP078 |