AE / SAE Reporting
Capture adverse and serious adverse events the moment they happen. Structured forms guide severity and causality capture, while automated escalation alerts notify the right people without delay.
What you get
AE/SAE Reporting shortens the gap between an event occurring and the right people knowing about it. A subject can flag a symptom from the mobile app the moment it happens; the site receives it instantly and the CRC/PI complete structured severity and causality assessments on desktop. Serious events trigger automated escalation to the PI and safety team, and every report is tracked through follow-up to resolution with an exportable safety record.
Safety
AE / SAE Reporting
Purpose-built for hybrid & decentralized trials — one workflow across desktop and mobile.
Desktop for study teams, mobile for subjects
AE / SAE Reporting works across the ProCTTH hybrid platform — site staff (CRC, PI, CRA) work on the desktop web console, while subjects access the study from the mobile app.
Desktop console
CRC · PI · CRA
CRC and PI review incoming events, complete severity and causality assessments, manage the SAE workflow and follow-up, and export safety reports for the sponsor.
Mobile app
Subject
Subjects report symptoms and adverse events in real time from the mobile app, attach photos or notes, and respond to follow-up questions.
From setup to outcome
Report the event
Subjects flag symptoms from the app, or site staff log events directly, in real time.
Assess structurally
CRC/PI complete guided severity and causality assessments on the console.
Escalate automatically
Serious events trigger automated alerts to the PI and safety team without delay.
Track to resolution
Each event is followed up and tracked to closure, with exportable safety reports.
Common questions
Can subjects report events themselves?
Yes. Subjects can report symptoms and adverse events in real time from the mobile app, with photos and notes.
How are serious events escalated?
SAEs trigger automated escalation alerts to the PI and safety team so nothing waits on manual hand-off.
Is there a follow-up workflow?
Every event runs through a follow-up workflow tracked to resolution, with exportable safety reports.