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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)

  • Jeffrey Dickinson

  • Ross Farrugia

  • Fanny Gautier

  • G Gayatri

  • Asha Chakma

  • Dinakar Kulkarni

  • Edoardo Mancini (ORCID)

  • Sadchla Mascary

  • Gordon Miller

  • Lina Patil

  • Sophie Shapcott

  • Eric Simms

  • Daniel Sjoberg (ORCID)

  • Stefan Thoma (ORCID)

  • Phillip Webster

  • Kangjie Zhang

  • Zelos Zhu

Other contributors:

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

  • GlaxoSmithKline LLC [copyright holder, funder]