Course Length:

1 day

Prerequisites:

None

Course Objectives:

§         Provide professionals with a detailed understanding of MedDRA structure

§         Provide a historical perspective on past MedDRA modifications and their impact on database maintenance

§         Provide insight into MedDRA structure validation techniques

§         Provide methods for comprehensive data retrieval

Course Benefits:

This course will enable the participant to:

§         Proficiently handle MedDRA updates

§         Identify MedDRA related issues which may require modification of the database

§         Differentiate between an internal issue versus an issue to be addressed by the MSSO

§         Assist in the design and development of queries

Course Outline:

1.      MedDRA Structure

§         Hierarchical - SOC, HLGT, HLT, PT, LLT

§         Special Search Category (SSC)

§         Multiaxial

§         Behind the scenes

-         8-digit code

-         Relationship among terms in the hierarchy

-         Tables

§         Examples of implications when dictionary integrity is not maintained

2.      Modifications to MedDRA

§         MedDRA updates

-         Structure integrity validation

-         SOPs to check for inconsistencies

§         Internal modifications

-         "Tweaking" MedDRA to meet internal needs

-         Flag designations

§         Processing change requests

3.      Database Management

§         Information capture

-         Audit trail

-         Field properties

§         Maintaining synonym table

§         Provisional terms

§         Noncurrency

4.      Tools

§         Browser functions

§         Current system query capability

5.      Data Extraction

§         Search strategies

§         Establishing search criteria

§         Creating Special Search Categories

§         Information presentation

§         Where to query

§         Field properties

6.      Summary Q&A