MedDRA-Coded AE Capture with Expedited Reporting Triggers
The Trialhelix AE reporting workflow supports safety data managers in Phase I and II trials — from initial AE entry and MedDRA coding through SUSAR identification and SAE narrative generation.
AE Reporting Procedure in Trialhelix
AE Capture and Initial Classification
Site staff enter the adverse event verbatim term in the AE eCRF form. CTCAE grade, relationship to study drug, seriousness flag, and onset/resolution dates are captured at entry with mandatory field enforcement. Edit checks validate date consistency and flag missing required fields.
MedDRA Auto-Coding
The verbatim term is submitted to MedDRA auto-coding against the current dictionary version. High-confidence matches are applied automatically; low-confidence matches are routed to the medical coder for manual review. All coding decisions — auto and manual — are logged to the audit trail.
Seriousness and Expectedness Assessment
Serious AEs trigger an expedited review workflow. The medical monitor is notified and reviews the SAE record within the system — confirming seriousness criteria (per ICH-E2A), assessing expectedness against the Investigator Brochure, and providing causality assessment.
SUSAR Identification and Expedited Reporting
When an SAE meets SUSAR criteria (serious, unexpected, related), the system alerts the safety data manager and sponsor with the applicable regulatory timeline — 7-day for fatal/life-threatening, 15-day for other SUSARs. The expedited report package (narrative, MedDRA-coded case summary) is generated within the workflow.
SDTM AE Domain Update
Every AE update — new event, follow-up information, outcome change — automatically updates the SDTM AE domain record. The TEAE classification (treatment-emergent) is derived from the exposure and AE onset dates per the SAP definition.
AE Workflow Capabilities
MedDRA Coding Integration
Current MedDRA version maintained. Auto-coding against PT with SOC hierarchy. Manual coder review workflow with approval record. Verbatim-to-PT mapping history retained for regulatory submission.
CTCAE Grade Capture
CTCAE grade (1–5) captured at AE entry. Grade changes over time are tracked with reason-for-change. Grade-5 events trigger immediate notification to the medical monitor and CDM lead.
SAE Expedited Reporting Alerts
SUSAR criteria checked against the protocol's expectedness definition and IB. Automated alerts to sponsor safety contact and clinical operations when expedited reporting timelines are triggered. Reporting deadline tracked within the workflow.
SAE Narrative Generation
SAE narrative structured format is auto-populated from the eCRF data — subject demographics, relevant medical history, study drug exposure, AE onset and course, treatment, and outcome. Medical monitor edits are tracked with audit trail entries.
AE Summary Reports
Real-time AE summary by SOC and PT for sponsor data review meetings. TEAE frequency tables in TLF-ready format. Signal detection view showing events that have increased in frequency since the last data cut.
SDTM AE Domain Auto-Update
AE data updates flow to the SDTM AE domain without manual CDM intervention. TEAE classification, AESER flag, and MedDRA codes are derived from eCRF data per the protocol-specific mapping rules configured at study build.
See the AE Workflow on Your Study Type
Phase I oncology FIH studies have different AE reporting requirements than Phase II rare disease studies. A technical call covers your specific protocol's safety reporting setup.