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).
Maintainer: Ben Straub ben.x.straub@gsk.com
Authors:
Stefan Bundfuss (ORCID)
Jeffrey Dickinson
Ross Farrugia
Fanny Gautier
Dinakar Kulkarni
Edoardo Mancini (ORCID)
Sadchla Mascary
Gordon Miller
Jim Rothstein (ORCID)
Sophie Shapcott
Eric Simms
Daniel Sjoberg (ORCID)
Stefan Thoma (ORCID)
Phillip Webster
Zelos Zhu
Other contributors:
F. Hoffmann-La Roche AG [copyright holder, funder]
GlaxoSmithKline LLC [copyright holder, funder]
Useful links:
Report bugs at https://github.com/pharmaverse/admiral/issues
Other internal:
extract_duplicate_records()
,
format.basket_select()
,
signal_duplicate_records()