Using SDTM, ADaM, and SEND

Overview


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It's a pretty safe bet that most people's first introduction to CDISC is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a consistent manner. It helps to reduce review time and makes cross-study analysis easier.

Another content standard, the Analysis Data Model (ADaM), aims to perform a similar function for analysis datasets. Likewise, the Standard for Exchange of Nonclinical Data (SEND) defines standardized In this article, Formedix discusses using SDTM, ADaM and SEND for regulatory submission.

This content is provided by Formedix, and any views and opinions expressed do not necessarily reflect those of Outsourcing-Pharma.com

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