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Quick summary
  • Create your CSCR, usually one per product, from a template in Templates or your own file.
  • A live Hazard Log Summary keeps the report’s hazards current, filtered to its product and risk.
  • In Tasks, a product can have 2 CSCR tasks: completing and maintaining the report, and your CSO’s sign-off.

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Create it in Assuric

1

Find the template

Go to Documents and open the Templates tab. In Assuric Templates, find [TEMPLATE] Clinical Safety Case Report.
2

Create it from the template

Click Create from template on its row, then:
  • Fill in the document’s details, permissions and review schedule.
  • Set Products to the product the report covers.
  • Tick Controlled if it needs a formal review and approval cycle.
Click Create to open the report with its placeholders filled in from your workspace.
To use a clinical safety case report (CSCR) you’ve written, upload it instead (.docx, .doc or .xlsx, up to 50 MB), then replace a pasted hazard table with a live one, and repeated values with placeholders. With several products, clone your first CSCR to a template so you don’t rebuild its structure (⋯ → Clone to template on the Documents tab), then start each other report from it.

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Assuric features for your CSCR

To edit, approve and publish the report, see Manage, approve and publish clinical documents.

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The CSCR as a task

Filter Tasks for “Safety Case Report” and the Product group expands into each product’s CSCR tasks.
The Tasks page filtered to Clinical Safety Case Report, showing the task recurring per product

The Clinical Safety Case Report task, filtered and expanded. Each product (Procedure Consent, NEWS2 App, Appointment Manager and others) has a completed-and-maintained task and a signed-off-by-the-CSO task. A product can be missing one: Compass Decisions has only the first.

You track and sign off each product’s report separately.

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What goes in a CSCR

To be written by Assuric’s clinical safety officers. This section will cover:
  • What the CSCR is for, and who reads it
  • The sections a CSCR needs, and which template sections map to them
  • How the CSCR refers to the CRMP and the hazard log

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Which hazards the CSCR discusses

To be written by Assuric’s clinical safety officers. This section will cover:
  • Which hazards a CSCR must discuss (for example, those with a high initial or residual risk)
  • How to set the Hazard Log Summary filters to match
  • How to discuss hazards whose residual risk stays undesirable, and the ALARP justification

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Sign-off and keeping the CSCR current

To be written by Assuric’s clinical safety officers. This section will cover:
  • What the CSO checks before signing off
  • Which changes to the product or hazard log should trigger a new approved version
  • Sharing the approved CSCR with deploying organisations

Clinical documentation

The Assuric features that keep clinical safety documents current.

Manage, approve and publish clinical documents

Edit, version, approve and publish your CSCR.