Course Length:

1 day

Prerequisites:

None

Objectives:

§         Provide users with a basic understanding of MedDRA structure

§         Provide users with an overview of coding concepts and specific knowledge of MedDRA.

§         Introduce users to ICH MedDRA Terms Selection: Points to Consider classification guideline

§         Provide practical coding experience with MedDRA

§         Provide first hand experience on the implications of MedDRA coding and its impacts on data management and retrieval

§         Provide an overview of MedDRA Coding Quality Assurance

Course Benefits:

At the conclusion of this course, participants will be able to:

§         Navigate throughout MedDRA with confidence

§         Appreciate the need for and appropriately apply classification guidelines

§         Appreciate the complexities of performing data classification and retrieval using MedDRA

§         Recognize potential MedDRA related problems

Course Outline:

1.      Coding Concepts

§         Objectives of coding

§         Necessity for coding guidelines

§         Review of ICH guidelines and examples of company coding guidelines

2.      Overview of Current Dictionary and Dictionary Types

§         Adverse reactions, diagnoses, drugs, and procedures

§         HARTS, COSTART, WHO-ART

§         MedDRA inclusion of prior dictionaries

3.      MedDRA Specifics

§         Dictionary intent

§         Dictionary structure and impact on coding and data retrieval strategy

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

-         Multiaxial

-         Associative

4.      MedDRA "Tools"

§         Autoencoder

§         Browser

§         Reference texts

-         Coder's manual

-         Medical abbreviations - common versus standard

-         Lab references

-         Medical text

-         Medical dictionary

§         Online resources

5.      MedDRA Coding: Application and Implications

§         Introduction to MedDRA coding techniques

-         Top down approach

-         Bottom up approach

§         Applying classroom theory to real life examples

§         Explanation of the step by step thought process required to find the most appropriate LLT in MedDRA

-         Reinforcing this process through multiple practice exercises with company specific data (string text)

-         Applying ICH guidelines

§         Overview of implications on data analysis and extraction

§         Discussion of examples demonstrating the impact of coding on data management and retrieval

6.      MedDRA Quality Assurance (QA)

§         Concepts in QA

-         Uniformity across coders

-         Uniformity across verbatim text concepts

-         Uniformity across national cultures, diversity

§         Training a QA group

§         Creating uniformity across the QA staff

-         Documenting the Process

-         Tracking Results and Feedback

7.      Summary and Q&A