MedDRA® TERM SELECTION: POINTS TO CONSIDER
Release 3.13 Based on MedDRA Version 12.1 ICH-Endorsed Guide for MedDRA Users

Application to Adverse Drug Reactions /Adverse Events

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Medical and Social History & Indications

1 October 2009

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Table of Contents

1.0 1.1 1.2 1.3 1.4 2.0 2.1 2.2 2.3 2.4 2.5 2.6 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 3.19 3.20 3.21 3.22 3.23 3.24 3.25 3.26 4.0 4.1 4.2

INTRODUCTION ...................................................................................................................... 4 OBJECTIVE OF THIS DOCUMENT ................................................................................................. 4 PURPOSES OF USING MEDDRA ................................................................................................. 5 BACKGROUND ........................................................................................................................... 5 SCOPE OF THE POINTS TO CONSIDER ......................................................................................... 6 GENERAL PRINCIPLES ......................................................................................................... 6 QUALITY OF SOURCE DATA ....................................................................................................... 6 LEVEL OF TERM SELECTION ....................................................................................................... 6 USE OF