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    Study Data Standardisation Plan (SDSP) Package

      Study Data Standardisation Plan (SDSP) Package

      Jul 08, 2024

      OverviewVersion/Publication DateLink 
      The SDSP documents the data standardisation approach for clinical and nonclinical studies within a development program. This Package includes information on the CBER appendix, with proposed domain/variable usage. The SDSP Package includes the template, completion guidelines, sponsor implementation guide, and examples.Version 1.0, 16-Jan-2018

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