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A toolbox for programming Clinical Data Interchange Standards Consortium (CDISC) compliant Analysis Data Model (ADaM) datasets in R. ADaM datasets are a mandatory part of any New Drug or Biologics License Application submitted to the United States Food and Drug Administration (FDA). Analysis derivations are implemented in accordance with the "Analysis Data Model Implementation Guide" (CDISC Analysis Data Model Team, 2021, https://www.cdisc.org/standards/foundational/adam).

Author

Maintainer: Ben Straub ben.x.straub@gsk.com

Authors:

  • Stefan Bundfuss (ORCID)

  • Arianna Cascone (ORCID)

  • Jeffrey Dickinson

  • Ross Farrugia

  • Fanny Gautier

  • G Gayatri

  • Dinakar Kulkarni

  • Edoardo Mancini (ORCID)

  • Gordon Miller

  • Jim Rothstein (ORCID)

  • Daniel Sjoberg (ORCID)

  • Stefan Thoma (ORCID)

  • Junze Zhang

Other contributors:

  • F. Hoffmann-La Roche AG [copyright holder, funder]

  • GlaxoSmithKline LLC [copyright holder, funder]