Clinical Safety documentation

Documentation that supports clinical risk management. They underpin the scope and requirement of the clinical safety team.

Clinical risk management

Document templates

These templates are intended for download by our customers. You can use and rebrand them to help you complete your clinical risk management requirements.

Clinical safety case report template

docx 58 KB

Clinical risk management system template

docx 68 KB

Clinical risk management plan template

docx 69 KB

Clinical safety hazard log template

xlsx 87 KB

Digital First Online Consult Video Consult

This DFOCVC generic hazard log records generic hazards for each individual capability in separate tabs.

They are derived from similar health IT systems under both normal and fault conditions, provided as a reference only and are not to be considered definitive.

DFOCVC generic hazard log v2.0

xlsx 150 KB

Clinical safety guidance

Clinical risk management data safety

Guidance on the management of data safety risks in the manufacture, deployment and use of health IT systems.

Clinical risk management data safety

pdf 669 KB

Clinical Risk Management - Agile Development Implementation Guidance

pdf 362 KB

ARTICLE

Healthcare supplementary guidance for Assurance of Machine Learning for use in Autonomous Systems

This supplementary guidance provides healthcare specific considerations that should be reviewed in parallel when applying the Assurance of Machine Learning for use in Autonomous Systems methodology for establishing justified confidence in the safety of machine learning components within a wider system and context.

Further information

Solution Assurance

We enable the development of safe, secure and effective health and social care technology.

Last edited: 21 July 2023 4:03 pm