Transcription of CLINICAL SAFETY DATA MANAGEMENT …
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CLINICAL SAFETY DATA MANAGEMENT …
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE CLINICAL SAFETY data MANAGEMENT : DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A Current Step 4 version dated 27 October 1994 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
Clinical Safety Data Management The following definitions, with input from the WHO Collaborative Centre, have been agreed: 1. Adverse Event (or Adverse Experience)
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SUSPECTED ADVERSE DRUG REACTION, SUSPECTED ADVERSE DRUG REACTION REPORTING FORM, Adverse Drug, ADVERSE DRUG REACTION-CAUSALITY, ADVERSE DRUG REACTION-CAUSALITY ASSESSMENT, Definitions, Adverse, Adverse reaction, System for standardised case causality assessment, Drug, ABCDE SYSTEM ADVERSE EVENTS OF TYPE, Draft guidance for industry on reporting, Adverse Event Report Form and Guidelines For, Adverse Event Report Form and Guidelines For Clinical Studies, Drug-Induced Hematologic Disorders