Reduce risk & increase regulatory compliance with our complete guide to CDISC standards management
Whether you’re new to the complex world of CDISC data standards, or just need a refresher, this guide provides a practical blueprint for implementing standards efficiently – and at scale.
Why this guide is a must-have
💪 Essential steps to ensure datasets meet global regulatory requirements (FDA, PMDA etc)
⚠️ Explains how to implement CDISC data standards before data collection
💡 A key step in understanding how SDTM, SEND, ADaM, and USDM fit together across the clinical trial lifecycle
Top 3 critical failures in standards management
- Treating standards as an afterthought (leads to rework, delays, and increased risk)
- Managing standards at scale in spreadsheets
- Failing to keep pace with changes to CDISC data standards, and underestimating regulatory complexity
What you’ll learn in this guide
- The purpose and strategic value of clinical data standards
- The differences and relationships between:
- SDTM
- ADaM
- SEND
- USDM
- A step-by-step overview of a typical standards management process
- The five most common standards challenges
- How to tackle these challenges
- The role of a clinical metadata repository in CDISC data standards management
Download this free resource and take control of your CDISC compliance➡️
About the author
Ed Chappell
Subject Matter Expert & 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 CDISC data standards, and supporting customers with FDA submissions and Interim Analysis SDTM needs.
