Transcription of http://analytics.ncsu.edu/sesug/2014/PH-11.pdf
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http://analytics.ncsu.edu/sesug/2014/PH-11.pdf
1 Paper PH-90 SDTM What? ADaM Who? A Programmer s Introduction to CDISC Venita DePuy, Bowden Analytics ABSTRACT Most programmers in the pharmaceutical industry have at least heard of CDISC, but may not be familiar with the overall data structure, naming conventions, and variable requirements for SDTM and ADaM datasets. This overview will provide a general introduction to CDISC from a programing standpoint, including the creation of the standard SDTM domains and supplemental datasets, and subsequent creation of ADaM datasets. Time permitting, we will also discuss when it might be preferable to do a CDISC-like dataset instead of a dataset that fully conforms to CDISC standards. INTRODUCTION CDISC is the Clinical Data Interchange Standards Consortium ( ), whose mission is to develop and support platform-independent data standards. While they have also developed other guidelines, such as for data collection (Clinical Data Acquisition Standards Harmonization, CDASH), this paper focusses on the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) structures.
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