Course Length:

1 day

Prerequisite:

Although there is no prerequisite, attendees of this course would benefit from participation in the MedDRA for Coders/Clinical Associates course.

Course Objectives:

§        Examine MedDRA structure from a retrieval perspective

§        Focus on common challenges in MedDRA coded data retrieval

§        Provide methods for comprehensive retrieval using multiaxiality and Special Search Categories/Standardized MedDRA Queries

§        Perform exercises to establish search criteria for assigned medical concepts

§        Perform searches against a dataset

§        Provide insight into data presentation

Course Benefits:

This course will enable the participant to:

§        Use a MedDRA browser in order to create retrieval queries

§        Build efficient, comprehensive search criteria for medical concepts using MedDRA terms

§        Perform MedDRA-coded data retrieval

§        Associate data collection, application of coding guidelines and MedDRA coding with data retrieval, analysis and presentation

Course Outline:

1.      MedDRA  Structure

§       Primary/secondary SOCs

§       Single axial SOCs

§       Pathways to multiple SOCs

§       SSC/SMQ

§       LLT currency

2.      Tools

§       Coding tool

§       Retrieval tool

§       Attendee use of browser to demonstrate MedDRA structure concepts

3.      Developing Data Retreival Strategies using MedDRA Terms

§        Primary SOC search

§        Multi-axial search

§        SSC/SMQ search criteria

§        Search strategies

-         Taking advantage of multiaxial structure

-         Casting a wide net versus a narrow restrictive query (LLT, PT, HLT, HLGT)

-         Examples and discussion of various search strategies and resulting data retrieved

4.      Common Challenges Encountered in MedDRA Data Retrieval

§        Data collection impact

§        Coding guidelines application

§        MedDRA coding expertise

§        MedDRA versioning

§        Retrieval criteria

5.      Data Retrieval Exercises

§        Application of classroom theory to actual building of queries for assigned medical concepts

§        Use of records and a retrieval database

§        Comparison of different results with different retrieval strategies

6.      Data Analysis/Presentation with MedDRA

§        Primary SOC analysis/presentation

§        Secondary SOC analysis/presentation

§        PT vs. HLT level for data presentation

§        Codes vs. raw text

7.      Summary Q&A