Clinical Safety Data Management临床安全数据管理(E2A).pdf

European Medicines Agency June 1995 CPMP/ICH/377/95 ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Step 5 NOTE FOR GUIDANCE ON CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/377/95) APPROVAL BY CPMP November 1994 DATE FOR COMING INTO OPERATION June 1995 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: mail@ EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline 1. INTRODUCTION It is important to harmonise the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development. Thus, agreed definitions and terminology, as well as procedures, will ensure uniform Good Clinical Practice standards in this area. The initiatives already undertaken for marketed medicines through the CIOMS-1 and CIOMS-2 Working Groups on expedited (alert) reports and periodic safety update reporting,