Tested before it carries real cases
The workflow runs through simulated events before go-live, so timeline tracking and routing are proven, not assumed.
What's included
What goes into workflow setup
- Intake channels configured for how sites and CRAs will submit SAE reports, matched to the protocol's reporting requirements
- Triage and routing rules built so events move to the right reviewer without manual handoffs
- Regulatory clock tracking configured against the timelines set in the Safety Management Plan
- Notification and escalation rules set for events approaching a reporting deadline
- The workflow tested end-to-end with simulated cases before go-live
- Sites and CRAs briefed on the workflow as part of Site and CRA Safety Reporting Training
Built for the reconciliation to come
Consistent, structured intake here is what makes the SAE Reconciliation Plan workable once cases start flowing.