Clinical Safety: Overview

Quick summary

Build a hazard log for each product and publish approved versions on your Trust Centre.
Approving a new version can move every published copy to it.
One incident log holds clinical and security incidents, including reports from outside your organisation.

What’s in this section

In the app, Clinical Safety holds Overview, Hazard Log and Incidents.

Group	Page	Covers
Hazard log	Hazard log overview	How the hazard log fits together, and how to read its table
	Set up hazard IDs and statuses	Choose your hazard ID pattern, and use or add statuses for hazards and controls
	Create a hazard	Log a hazard and score its initial and residual risk
	Causes, controls and evidence	How hazards, causes, controls and evidence link, and when to copy or link
	Manage your hazard log with AI	Use Ask Assuric to draft hazards, causes and controls
	Manage hazards	Archive instead of deleting, and what to do when something changes
	Risk scales and thresholds	The likelihood and severity scales, the risk matrix and the as low as reasonably practicable (ALARP) threshold
	Approve and version your hazard log	Approve a new version and choose which published copies move to it
	Share and publish your hazard log	Publish a bundle of approved hazard logs to your Trust Centre and share it
	Export a hazard log	Download your hazard log
Incidents	Create an incident	Record a clinical or security incident
	Import incidents from incident.io	Bring incidents in from incident.io
	Set up incident reporting	How staff and people outside your organisation report incidents
	Manage your incident log	Track incidents, link them to hazards and risks, and close them
	Export your incident log	Download your incident log
Clinical documentation	Clinical documentation	The Assuric features that keep clinical safety documents current
	Clinical risk management plan (CRMP)	Create your CRMP
	Clinical safety case report (CSCR)	Create your CSCR, and the CSCR tasks
	Manage, approve and publish clinical documents	Edit, version, approve and publish clinical safety documents
FAQ	Clinical Safety FAQ	Quick answers to common questions

What’s covered elsewhere

Covers	Where
Writing, versioning and approving documents in general	Documents: Overview
Setting up your Trust Centre, and who can see what once it’s live	Trust Centre: Overview
Drafting hazards with Ask Assuric	Add hazards with the Hazard Log Assistant
Security risks, and the incident log they share with Clinical Safety	Incidents overview

Open Clinical Safety → Overview in the sidebar to see this area’s frameworks, each with its progress and a Tasks link. Terms like initial risk, residual risk and ALARP are in the glossary.

Framework	What it means for you
Class I UK MD	Low-risk software as a medical device (UK MDR, MHRA), which you do for each product
DCB0129	The NHS clinical safety standard for manufacturers, which you do for each product, with tasks beyond the Clinical Safety area
DCB0160	The NHS standard for organisations that deploy your product, which you cover in your hazard log rather than as a framework, recording their controls as transferred controls with Responsibility set to Deploying Org
ISO 14971	Risk management for medical devices, with its own tasks, enabled separately from DCB0129
CQC	Care Quality Commission regulations for online healthcare providers, which you do once for your organisation and will also find under Clinical Governance in the sidebar

The Frameworks grid showing the DCB0129 card — DCB0129 in Frameworks, with its own percentage and task count. ISO 14971 sits directly below it: a related standard, locked (0 tasks) until it's enabled for this workspace.

Frameworks: Overview lists every framework Assuric tracks.

Share and publish your hazard log

Give each customer a link to the approved hazard logs for the products they use.

Create a hazard

Log a hazard and score its risk.

Assuric Overview

Getting Started

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Clinical Safety

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Appendix

Clinical Safety: Overview

What’s in this section

What’s covered elsewhere

Share and publish your hazard log

Create a hazard

​What’s in this section

​What’s covered elsewhere

​Related frameworks

​Related articles

Share and publish your hazard log

Create a hazard

What’s in this section

What’s covered elsewhere

Related frameworks

Related articles