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Using SDTM, ADaM, and SEND

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Using SDTM, ADaM, and SEND

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.

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