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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