admiralonco

Oncology Extension Package for ADaM in 'R' Asset Library

Stephen Gormley, Teckla Akinyi, Stefan Bundfuss, Amit Jain, Samia Kabi, Andrew Smith, Vinh Nguyen, Hinal Patel, Ross Farrugia

Last update: 20 December 2023

Copyright license: Apache License

Software version identifier: 0.3.0, 0.1.0, 0.2.0, 0.4.0, 0.5.0, 1.0.0

Description

Programming oncology specific 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>). The package is an extension package of the 'admiral' package.

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