Clinical Study

Using SDTM, ADaM, & SEND for Regulatory Submission

Format: PDF file | Document type: Clinical Study

Using SDTM, ADaM, & SEND for Regulatory Submission

Related categories: Regulatory affairs

It’s a 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, helping to reduce review time and facilitating cross study analysis. 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 domains for non-clinical data.

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