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The Challenges of Mapping Source Data to SDTM
The Challenges of Mapping Source Data to SDTM

Best practices to incorporate bi-directional mapping for your source data workflow

Wendy Young avatar
Written by Wendy Young
Updated this week

Our industry faces some inherent challenges in working with heterogeneous source data and navigating evolving regulatory requirements. How do we tackle complexity in mapping?

It's also important to recognize and understand the importance of maintaining clear, auditable documentation and traceability from source data to final SDTM variables, ensuring every mapping decision is justified for regulatory compliance.

On 27 March 2025, P21's Amy Garrett walked us through effective methods for managing updates and collaborating seamlessly among data managers, statisticians, and regulatory experts—even when using tools that lack robust version control.

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