admiralvaccine - Vaccine Extension Package for ADaM in 'R' Asset Library
Programming vaccine specific Clinical Data Interchange
Standards Consortium (CDISC) compliant Analysis Data Model
(ADaM) datasets in 'R'. Flat model is followed as per Center
for Biologics Evaluation and Research (CBER) guidelines for
creating vaccine specific domains. 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/adamig-v1-3-release-package>).
The package is an extension package of the 'admiral' package.