Module 6

03/10/2024

Electronic Reporting overview

M2 (ESTRI) transport vehicle, protective security and format definitions

M1 Medical Terminology

Regulatory Authority (e.g. MHRA) or the Agency (EMA)

E2B (R3) Format of Report

17

17

Harmonised Electronic Reporting of ICSRs

ICH M2 DTD Electronic Standards

ICH M1 MedDRA

ICH E2B(R3) Data Elements

ICH compliant Electronic ICSR

Regulatory Agencies

18

18

9