meddradataretrievalandpresentation.docVIP

MedDRA? DATA RETRIEVAL AND PRESENTATION:POINTS TO CONSIDER ICH-Endorsed Guide for MedDRA Users on Data Output Release 3.3 Based on MedDRA Version 15.0 1 April 2012 ? Copyright ICH Secretariat (c/o IFPMA) Copying is permitted, with reference to source, but material in this publication may not be used in any documentation or electronic media which is offered for sale, without the prior permission of the copyright owner. IFPMA Chemin Louis-Dunant, 15 P.O. Box 195 1211 Geneva 20 Switzerland Tel: +41 (22) 338 32 00 Fax: +41 (22) 338 32 99 / Table of Contents Section 1 – INTRODUCTION 1 1.1 – Objectives of this Document 2 1.2 – Reasons to Use MedDRA 2 1.3 – How to Use this Document 2 Section 2 – GENERAL PRINCIPLES 4 2.1 – Quality of Source Data 4 2.1.1 Data conversion considerations 4 2.1.2 Impact of data conversion method 4 2.2 – Documentation of Data Retrieval and Presentation Practices 5 2.3 – Do Not Alter MedDRA 5 2.4 – Organization-Specific Data Characteristics 6 2.5 – Characteristics of MedDRA that Impact Data Retrieval and Analysis 7 2.5.1 Grouping terms (HLTs and HLGTs) 7 Review terms within a grouping term 7 2.5.2 Granularity 8 2.5.3 Multi-axiality 8 Primary SOC assignment rules 8 Non multi-axial SOCs 9 Clinically related PTs 10 2.6 – MedDRA Versioning 11 Section 3 – GENERAL QUERIES AND RETRIEVAL 14 3.1 – General Principles 14 3.1.1 Graphical displays 16 3.1.2 Patient subpopulations 16 3.2 – Overall Presentation of Safety Profiles 16 3.2.1 Overview by primary System Organ Class 17 3.2.2 Overall presentations of small datasets 18 3.2.3 Focused searches 19 Focused searches by secondary SOC assignments 19 Section 4 – STANDARDISED MedDRA QUERIES 20 4.1 – Introduction 20 4.2 – SMQ Benefits 21 4.3 – SMQ Limitations 21 4.4 – SMQ Modifications and Organization-Constructed Queries 21 4.5 – SMQs and MedDRA Version Changes 21 4.6 – SMQs – Impact of MedDRA Legacy Data Conversion 22 4.7 – SMQ Change Requests 23 4.8 – SMQ Technical Tools 23