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This document is a major release of the SDTMStudy Data Tabulation Model. The content of the model has been rearranged and revised to update explanatory text. Tables have been revised to separate material previously included in the Description column into separate metadata, as described in the next section.

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  The SDTM has evolved to support a broad range of study types and regulated products, and is expected to evolve further to support an even broader range of study data. Implementation guides for applying the model to each type of data and guidance on controlled terminology are published separately.

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