AE vs SAE vs SUSAR: Key Differences in Safety Reporting
Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. Updated for 2026 with ICH E6(R3), EU CTR 536/2014 CTIS, FDA Dec 2025 guidances, and ICH E2B(R3) mandate. Covers definitions, causality, and expedited reporting timelines.