Safety Alerts
Real-time safety monitoring and alert management
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Critical Alerts
1
High Priority
2
New Alerts
0
Escalated
1
Unexpected Cardiac Event - Immediate Attention Required
CRITICAL
ESCALATED
Serious Adverse Event10/1/2025, 8:30:00 AM
Patient experienced acute myocardial infarction 48 hours post-dose. Currently hospitalized and stable.
Trial:Phase 3 Cardiovascular Study
Participant:P-001234
Reported by:Dr. Sarah Chen
Assigned to:Safety Committee
Due:10/2/2025, 8:30:00 AM
Elevated Liver Enzymes - Multiple Participants
HIGH
INVESTIGATING
Lab Abnormality10/1/2025, 2:15:00 PM3 related events
Three participants showing ALT/AST levels >3x ULN. Trend analysis suggests dose-dependent relationship.
Trial:Phase 2 Hepatic Safety Study
Reported by:Dr. Michael Park
Assigned to:Dr. Emily Rodriguez
Due:10/3/2025, 5:00:00 PM
Dosing Schedule Deviation - Site 05
MEDIUM
ACKNOWLEDGED
Protocol Deviation10/1/2025, 10:00:00 AM1 related event
Patient received dose 4 hours outside protocol window. No adverse effects reported.
Trial:Phase 3 Oncology Trial
Participant:P-005678
Reported by:Site Coordinator - Site 05
Assigned to:Dr. James Wilson
Pregnancy Reported - Participant Withdrawn
HIGH
RESOLVED
Pregnancy Report9/30/2025, 4:45:00 PM
Female participant of childbearing potential reported positive pregnancy test. Immediately discontinued from study per protocol.
Trial:Phase 2 Rheumatology Study
Participant:P-009012
Reported by:Dr. Anna Martinez
Assigned to:Dr. Sarah Chen
Increased Reports of Headache
LOW
INVESTIGATING
Mild Adverse Event9/30/2025, 9:00:00 AM12 related events
Trend analysis shows 15% increase in headache reports over past 2 weeks. All Grade 1, self-limiting.
Trial:Phase 3 Cardiovascular Study
Reported by:Data Safety Monitoring Board
Assigned to:Dr. Michael Park