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).
See also
Useful links:
Report bugs at https://github.com/pharmaverse/admiral/issues
Other internal:
extract_duplicate_records(),
format.basket_select(),
signal_duplicate_records()
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]