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Clinical Safety Incident

This guide explains how to log a new Clinical Safety Incident in the Assuric platform

Step 1: Start a New Incident

  1. Navigate to the Clinical Safety Incidents section from the left-hand menu.

  2. Click New Incident.

Step 2: Enter Incident Details

  1. Provide a description of the incident.

  2. Enter the cause (e.g., product bug).

    • You can select an existing cause or create a new one by clicking Add Cause.

  3. Set the severity (e.g., Critical).

  4. Specify the type of incident (Clinical or Security).

    • In this case, it is a Clinical Incident.

  5. Set the product(s) involved

Step 3: Save the Incident

  1. Click Add Incident to save the entry.

  2. Additional fields will appear for further details.

Step 4: Complete Incident Information

  1. Status: Keep the incident status updated (e.g., Open until resolved).

  2. Clinical Owner: Assign responsibility by tagging yourself or another owner.

  3. Risk Assessment: Complete if required.

  4. Link to Hazard Log:

    • Click Link and select the relevant hazard.

Step 5: Add Supporting Details

  • Themes: Assign an incident theme if applicable.

  • Reporter: Record who reported the incident.

  • Evidence & Root Cause: Attach any supporting files, analyses, or reports. From the evidence pop-out, choose one of the following:

    • Upload a file (e.g., screenshot, video, spreadsheet)

    • Add a link

    • Add a free-text note

    • Select a document from the Assuric platform

  • Outcomes & Lessons Learned: Document resolution outcomes and lessons.

  • Notes: Add any additional information.

Step 6: Review and Track

Once saved, the incident will appear in the Clinical Safety Incident list where you can track progress until it is closed.

✅ This process ensures clinical incidents are properly logged, linked to hazards, and documented with supporting evidence.

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