A Quick Guide to SDTM Dataset Creation

Our quick guide can help you create your SDTM datasets faster and easier.

What you’ll learn

The basics of SDTM dataset creation, including an SDTM dataset example

How to create SDTM datasets from source data

Best practice steps for CDISC SDTM mapping

The common SDTM mapping scenarios you might encounter

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.