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Quick summary
  • Create your CRMP from the template in Templates, or upload your own.
  • Write the people involved once, as a synced content block, and it updates in your CRMP and CSCRs.
  • Clinical Plan Schedule, under Settings → Meetings, sets your plan review reminders.

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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 Risk Management Plan.
2

Create it from the template

Click Create from template on its row, then:
  • Fill in the document’s details, permissions and review schedule.
  • Tag DCB0129 under Frameworks if it isn’t already.
  • Tick Controlled if the plan needs a formal review and approval cycle.
Click Create to open the plan with its placeholders filled in from your workspace.
To use a clinical risk management plan (CRMP) you’ve already written, upload it instead (.docx, .doc or .xlsx, up to 50 MB), then replace repeated names and roles with placeholders so they stay current.

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Assuric features for your CRMP

The document’s own Review schedule is separate from the Clinical Plan Schedule: changing one doesn’t change the other. To edit, approve and publish the plan, see Manage, approve and publish clinical documents.

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What goes in a CRMP

To be written by Assuric’s clinical safety officers. This section will cover:
  • What the CRMP is for, and how it relates to the hazard log and the CSCR
  • The sections a CRMP needs, and which template sections map to them
  • The scope: which products and releases the plan covers

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Roles and responsibilities in the CRMP

To be written by Assuric’s clinical safety officers. This section will cover:
  • Which roles the plan names (CSO, clinical safety team, product owners, top management)
  • What each role is responsible for under the plan
  • The CSO’s competency and appointment, and where that evidence sits in Assuric

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Keeping the CRMP current

To be written by Assuric’s clinical safety officers. This section will cover:
  • When to review the plan, beyond the scheduled review
  • What changes should trigger a new approved version
  • How the CRMP’s review fits with clinical safety meetings

Clinical documentation

The Assuric features that keep clinical safety documents current.

Meetings

Set how often you’re reminded to review your CRMP.