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The SDTM establishes a standard way to collect tabulate data across studies.

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Guidance in this section implements the SDTM and provides:

  • Basic data collection guidance and best practices.
  • Guidance for development of datasets

SDTM vs SENDfor TIG Product Description, Nonclinical, and Product Impact on Individual Health use cases. TheCDISCStandard for Exchange of Nonclinical Data (SEND) is a specialized approach to implement the SDTM for nonclinical research. Guidance for nonclinical use cases in this this section reflects implementation of the SDTM per SEND. Implementation of the SDTM is simply referred to as "SDTM" for all other use cases in this section.

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