Hit the ground running with our essential quick start guide to creating SDTM datasets
Learn the right way to approach SDTM dataset creation and get it right first time with this actionable guide. Master everything you need to know – from mapping source data to preparing submission deliverables.
Why this guide is a must-have
💡 Learn exactly what’s needed by the regulators, and why
💪 Teaches you how to go from source data to SDTM format
🚀 Equips you with practical mapping steps and examples that reduce errors and rework
Top 3 critical failures in SDTM dataset creation
❌ Lack of SDTM standards knowledge (without it, submissions are at high risk of rejection)
❌ Poorly mapped source data, leading to inconsistent domains (and costly rework)
❌ Lack of validation and quality checks, resulting in non-compliance and delayed approvals
This guide addresses these failings and puts you in the strongest position for creating compliant SDTM datasets. Simply complete the form to download your copy of the guide.
What you’ll learn in this guide
This guide bridges the gap between knowing SDTM standards, and how to apply them. Specifically you will learn:
- Step-by-step instructions – how to go from source data to SDTM
- How to handle the most common mapping scenarios
- How to align your SDTM submission with regulatory requirements
- Best practices for ensuring compliant, consistent data
- The relevance of the SDTM Implementation Guide (SDTMIG) in SDTM dataset creation
Submit the form now to get your hands on this essential guide ➡️
About the Author
Ed Chappell
Solutions Consultant
Ed Chappell has been working as a Solutions Consultant with Formedix, now part of Certara, for over 15 years, and has 22 years’ experience in data programming. As an expert in clinical data programming, Ed also supports customers with Interim Analysis (IA) SDTM and FDA SDTM clinical trial submissions. His specialist areas include: SDTM, SEND, Define-XML, ODM-XML and Dataset-XML.
