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CDISC (Clinical Data Interchange Standards Consortium) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models that you should familiarize yourself with. Three of these models are of particular importance to you who want to work with the SAS programmer in pharmaceutical industry.
(1) ADaM (Analysis Data Model): The CDISC AdaM team defines data set definition guidance for the analysis data structures. These data sets are designed for creating statistical summaries and analysis. As a statistical programmer, you may find these data sets to be the primary source for your reporting work. You may be very involved in the creation of these data sets.
(2) SDTM (Study Data Tabulation Model): The SDTM defines the data tabulation data sets that are to be sent to the FDA as part of a regulatrory submission. The FDA has endorsed the SDTM in its Electronic Common Technical Document (eCTD) guidance and the Study Data Specifications document. The SDTM was originally designed to simplify the production of case report tabulations (CRTs). Therefore, the SDTM is designed to be listed friendly, but not necessarily friendly for creating statistical summaries and analysis.
(3) Define-XML: Previously known as the “Case Report Tabulation Data Definition Specification,” Define-XML is the replacement model for the old data definition file sent to the FDA with electronic submissions. Define-XML is based on the CDISC operational data model (ODM) and is intended to provide a machine-readable version of define.pdf via define.xml. Because define.xml is a machine-readable file, the metadata about the submission data sets can easily be read by computer applications. This enables the FDA to work more easily with the data submtted to it. It may also enable you to do your work more efficiently and effectively if you are able to leverage your metadata.
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