admiralvaccine

Vaccine Extension Package for ADaM in 'R' Asset Library

Lee Armishaw, Sukalpo Saha, Vikram S, Dhivya Kanagaraj, Hilde Delanghe, Yamini Purna Bollu, Ilse Augustyns, Kalyani Bodicherla, Federico Baratin, Ben Straub, Arjun Rubalingam

Last update: 8 January 2024

Copyright license: Apache License

Software version identifier: 0.1.0, 0.2.0

Description

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.

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