One plan, no ambiguity mid-study
Decisions about timelines, roles, and escalation are made once, in writing, before conduct begins, not improvised case by case.
What's included
What goes into the plan
- Roles and responsibilities defined across the sponsor, NoyMed's safety team, and any partner vendors handling case data
- Expedited and periodic reporting timelines mapped to the applicable regulatory requirements for the study's regions
- Reconciliation cadence and method agreed for comparing the safety database against the clinical database
- Signal detection methodology and escalation thresholds referenced from the Signal Detection Plan
- Escalation and communication pathways defined for serious, unexpected, and other reportable events
- The plan reviewed and formally agreed with the sponsor before the database opens to real cases
Traceable back to the study record
The SMP sets the reconciliation cadence carried through into the SAE Reconciliation Plan and referenced at every subsequent reconciliation.
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