Safety

AE to SAE to expedited report without leaving the dataset.

Adverse events are captured on study forms with structured severity, causality, and outcome. Serious events start expedited clocks with escalating notifications, and reconciliation against CRF data is a query, not a quarterly project.

Structured safety capture

AE and SAE records use controlled vocabularies end to end, with a MedDRA coding queue and the dictionary version pinned per study.

Severity, causality, and outcome enums aligned to regulatory terminology
MedDRA coding queue with pinned dictionary versions
Baseline abnormalities flow from physical exam to medical history; post-baseline findings flow to adverse events

Deadlines that cannot be missed

Expedited reporting clocks (7 and 15 day, per 21 CFR 312.32) run from the moment criteria are met, with escalating notifications until the report is out.

Automatic expedited clocks with escalation
E2B(R3) ICSR export
SAE reconciliation view between safety records and captured CRF data

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