Adverse events
Severity-aware reporting deadlines per OHRP and 21 CFR 312.32. Real-time countdown on the dashboard. No more deadline calculations on the back of an envelope.
Active adverse events
Subject 0042 hospitalized 36h post-dose. Evaluating relatedness.
Death
24 hours
Unanticipated problem
7 days
Serious AE
15 days
Minor
30 days
The pain
Different AE severities have different reporting deadlines: 24 hours for death, 7 days for an unanticipated problem, 15 days for a serious event, 30 days for minor. Tracking the right deadline per event in a spreadsheet is how mistakes happen.
How it works
PI reports an AE — picks a severity (death, unanticipated problem, serious, minor). The system applies the right deadline per OHRP and 21 CFR 312.32.
Every active AE shows on the IRB office dashboard with days-until-deadline, color-coded by urgency. Overdue events flag in red.
Death and unanticipated-problem reports auto-escalate to the chair on submission. The chair can require board re-review before continuation.
AEs move from open → escalated → resolved with a documented response. Every transition is in the audit log.
Cited regulations
FAQ
Death: 24 hours to the IRB. Unanticipated problem involving risks: 7 calendar days. Other serious AEs: 15 days. Minor: 30 days. These align with OHRP guidance and 21 CFR 312.32 for FDA-regulated studies. Institutional policy can override with a per-study setting.
Per-institution AE policy is configurable. The default rules are the federal floor; you can shorten any deadline.
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The demo is a real, populated workspace. No signup, no email.