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Quick summary
  • Clinical safety documents are ordinary Assuric documents, but the hazard log is a log of its own, with its own approval.
  • A live Hazard Log Summary table shows the hazards a document must discuss, and updates as your hazard log changes.
  • An approved version freezes its Hazard Log Summary rows, so an approved CSCR records the hazard log at sign-off.
Clinical safety documents are ordinary Assuric documents, so everything in Documents applies to them.

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Clinical safety documents

DCB0129’s safety case has 3 deliverables, and customers usually ask for all three (see Choosing what to publish).

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The live hazard log table

The Hazard Log Summary is a live table of rows from your hazard log, and it updates when the log changes. To add one, type @ in the editor or click Placeholders in the toolbar, then pick Hazard Log Summary under Tables. Click the table to configure it:
  • Filters: Filter by Products, Filter by Status and Filter by Risk Level. The last has 2 switches, Undesirable initial risk and Undesirable residual risk. Each keeps hazards rated undesirable or unacceptable, and with both on, a hazard must meet both.
  • Columns and Appearance: as for any live table.
For example, filter a CSCR’s table to its product and undesirable residual risk to list the hazards the report must discuss. A hazard that later crosses the threshold appears without any edit.
A Clinical Safety Case Report draft showing the Live Hazard Log Summary table filtered to Appointment Manager, with five hazards and their initial and residual risk ratings

A CSCR draft with its Hazard Log Summary filtered to Appointment Manager. The bar above the table shows the product and status filters.

A Hazard Risk Summary Table counts your hazards in each risk band at initial and residual risk, and filters by product and status in the same way. Its bands are Low, Moderate, Significant, High and Very High (ratings 1 to 5), which the hazard log groups as:
  • Acceptable (1 and 2)
  • Undesirable (3)
  • Unacceptable (4 and 5)
A live table keeps updating in the editor, but an approved version freezes its rows, so an approved CSCR records the hazard log as it stood at sign-off.
What we recommendUse a Hazard Log Summary wherever a document lists hazards, rather than a pasted table.

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Placeholders, content blocks and version tables

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Clinical documentation pages

Create your CRMP and CSCR, then edit, approve and publish them.

Keep documents current with placeholders

Insert placeholders, configure a live table, and create your own blocks.

Clinical safety case report

Create your CSCR, with the hazard log pulled in.