Tutorial 15: Coding with Confidence

Coding conventions promote consistency in term selection and facilitate a common understanding of the MedDRA-coded data that is shared with regulatory authorities, within companies, and in collaborations with development and marketing partners. This workshop will present an overview of the key principles described in the ICH-endorsed “MedDRA Term Selection”, “Points to Consider” (MTS:PTC) document to provide a framework for the consistent and medically accurate coding of clinical data. Practical approaches will be demonstrated; the focus will be on common coding challenges (such as combination terms) and on the newer sections in the MTS:PTC such as medication errors, device related terms, medication exposures, and product quality ssues. Participants will have the opportunity to apply term selection principles by engaging in practical coding exercises with different types of clinical data. In an interactive group setting, participants will be encouraged to share best practices and discuss solutions to coding challenges that they have encountered in their daily work.

This workshop is designed for coders who already have experience using MedDRA and who wish to become more confident in their ability to perform medically accurate and consistent term selection.

 

At the conclusion of this tutorial, attendees will be able to:

• Describe how to code clinical safety data accurately and consistently with MedDRA
• Apply the principles described in the ICH-endorsed “MedDRA Term Selection: Points to Consider” document