A Best Practice Guide to CDISC SDTM Mapping

CDISC SDTM mapping made simple

Is a drug working? Are there side effects? Is it safe to continue with a trial?

These questions can be answered by clear, comprehensive data analytics. But to get this information, you must first produce quality CDISC SDTM datasets. Mapping your clinical trial data to CDISC’s SDTM format is no easy task.

Our best practice guide to CDISC SDTM mapping breaks down the process and gives you everything you need to know to successfully map to SDTM.

What you’ll learn

The basics of the CDISC SDTM structure

The importance of the SDTM mapping specification document

A best practice SDTM mapping process

Common mapping scenarios you might encounter

Tools to help you navigate the mapping process

About the authors

Ed Chappell

Solutions Consultant

Ed Chappell, Solutions Consultant with over 15 years’ tenure, is a recognized expert in clinical data programming and SDTM dataset mapping. He has been instrumental in developing the dataset mapper, delivering advanced training on SEND and SDTM standards, and supporting customers with FDA submissions and Interim Analysis SDTM needs.

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.