Standard Operating Procedures

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 025 Assessment & Registration of Trust Risk Rating for Research Studies

SOP 080 Study Data - Collection and Entry

SOP 081 Destruction of Waste IMP

SOP 024 Contract Negotiation and Review

SOP 016 Monitoring Research Studies

SOP 066 Subcontracting of Research Activities

Title	Tags	Description
Protocol Non Compliance (SOP 050).pdf	PTUC	SOP050
Trial Closure and End of Trial Reporting (SOP 021).pdf	PTUC	SOP021
Statistical Input into Clinical Trials (SOP 017).pdf	PTUC	SOP017
Sourcing of Investigational Medicinal Products for Papworth Sponsored Studies Manufacturing, Assembly and Labelling (SOP073).pdf	PTUC	SOP073
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
Randomisation of Papworth Sponsored Clinical Trials (SOP 018).pdf	PTUC	SOP018
Gaining Regulatory Approval from the MHRA (SOP 014).pdf	PTUC	SOP014
Serious Breach of Protocol or GCP in CTIMPS and Non-CE Marked Devices (SOP 051).pdf	PTUC	SOP051
Research Protocol Design (SOP 019).pdf	PTUC	SOP019
Financial Procedures for Research Projects (SOP 023).pdf	PTUC	SOP023
Version Control of Study Documentation (SOP 060).pdf	PTUC	SOP060
Project Management of Research Studies (SOP 009)	PTUC	SOP009
Risk Adapted Approach to Management of Investigational Clinical Trials (SOP 065).pdf	PTUC	SOP065
Patient Recruitment (SOP031).pdf	R&D	SOP031
Preparation of Regulatory Progress Reports including Periodic Safety Reporting and Annual Reports (SOP 062).pdf	PTUC	SOP062
Adverse Event Reporting (SOP 012).pdf	PTUC	SOP012
Ethics Approval of Research Studies(SOP 005).pdf	PTUC	SOP005
Informed Consent for Research Studies (SOP 003).pdf	R&D	SOP003
SOP082 Returns of IMP to Pharmacy.pdf	R&D	SOP082

Back to Information for researchers

Standard Operating Procedures

Where are we based?