> ## Documentation Index
> Fetch the complete documentation index at: https://docs.assuric.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Clinical safety case report

> Create a clinical safety case report (CSCR) for each product, pull in the hazards it must discuss with a live hazard log table, and track it through the CSCR tasks.

<Note>
  **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.
</Note>

## Create it in Assuric

<Steps>
  <Step title="Find the template">
    Go to **Documents** and open the **Templates** tab. In [Assuric Templates](/documents/templates-and-document-catalogue), find **\[TEMPLATE] Clinical Safety Case Report**.
  </Step>

  <Step title="Create it from the template">
    Click **Create from template** on its row, then:

    * Fill in the [document's details](/documents/creating-a-document#fill-in-the-document-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.
  </Step>
</Steps>

To use a clinical safety case report (CSCR) you've written, [upload it](/documents/creating-a-document#start-a-document) 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.

## Assuric features for your CSCR

| Feature | What it does in a CSCR |
| - | - |
| **Hazard Log Summary** | A [live table of your hazard log](/clinical-safety/clinical-documentation#the-live-hazard-log-table) that shows the hazards the report discusses: filter it to the report's product and to *Undesirable initial risk*, *Undesirable residual risk* or both (with both, a hazard must meet both) |
| **Version and approval tables** | **Document Version History** and **Document Approval Table** record each approved [version](/documents/versions-and-version-history) and who approved it |
| **Placeholders** | **Document Scoped Product(s)** names the report's product, and a **Role** [placeholder](/documents/default-placeholders#people-and-roles) names your clinical safety officer (CSO). A synced content block keeps the people involved the same as in your clinical risk management plan (CRMP) |

To edit, approve and publish the report, see [Manage, approve and publish clinical documents](/clinical-safety/managing-clinical-documents).

## The CSCR as a task

Filter **Tasks** for "Safety Case Report" and the *Product* group expands into each product's CSCR tasks.

<Frame caption="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.">
  <img src="https://mintcdn.com/assuric-docs/mqk2GxryRxlyCuQi/images/clinical-safety/dcb0129-cscr-tasks.png?fit=max&auto=format&n=mqk2GxryRxlyCuQi&q=85&s=648ee3f2ec1e607ccbc5c6ca72547bd2" alt="The Tasks page filtered to Clinical Safety Case Report, showing the task recurring per product" width="3200" height="2000" data-path="images/clinical-safety/dcb0129-cscr-tasks.png" />
</Frame>

You [track and sign off each product's report](/tasks/product-specific-tasks) separately.

## What goes in a CSCR

<Warning>
  **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
</Warning>

## Which hazards the CSCR discusses

<Warning>
  **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
</Warning>

## Sign-off and keeping the CSCR current

<Warning>
  **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
</Warning>

## Related articles

<Columns cols={2}>
  <Card title="Clinical documentation" icon="file-heart" href="/clinical-safety/clinical-documentation">
    The Assuric features that keep clinical safety documents current.
  </Card>

  <Card title="Manage, approve and publish clinical documents" icon="files" href="/clinical-safety/managing-clinical-documents">
    Edit, version, approve and publish your CSCR.
  </Card>
</Columns>


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