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- W2182225469 abstract "The CDISC Study Data Tabulation Model (SDTM) has become the industry standard for the regulatory submission of clinical trials data. The CDISC Analysis Data Model (ADaM) is not far behind in emerging as the industry standard for the analysis SAS datasets based upon the collected data. Pharmaceutical companies have begun to implement SDTM and, to some extent, ADaM. As part of this process, companies are evaluating whether to use the SDTM standard only for the regulatory submission, for which it is designed, or incorporate it into their operational standard as well. Some companies that are adopting SDTM as their operational standard are finding that a near-SDTM standard works better than strict conformance to the SDTM standard. When a near-SDTM standard is used at various stages in the full business process, the data contains either less than exact-SDTM (“SDTM-minus” as it is sometimes called) or more than exact-SDTM (“SDTM-plus” as it is sometimes called) or a mixture of both. This paper will discuss the use of SDTM as an operational data standard, the use of a near-SDTM standard with its SDTM-plus and SDTM-minus aspects, and how this relates to the development of analysis (ADaM) datasets." @default.
- W2182225469 created "2016-06-24" @default.
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- W2182225469 date "2006-01-01" @default.
- W2182225469 modified "2023-09-23" @default.
- W2182225469 title "SDTM, Plus or Minus" @default.
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