1.3 The Importance of Data Standards

Since its inception in 1997, the Clinical Data Interchange Standards Consortium (CDISC) has developed standards for data models, study designs, and supporting clinical trial documents. Standards for data models include the Study Data Tabulation Model (SDTM) for clinical trial data obtained from CRFs, questionnaires, and/or diaries; and the Analysis Data Model (ADaM) for derived data that support the analysis tables, listings, and figures common in drug applications [31,32]. At their core, CDISC standards are a means to streamline communications across the various parties involved in drug development, allowing for quicker review of drug submissions [33].
The SDTM model divides clinical trial data domains, ...

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