sdtm.oak - SDTM Data Transformation Engine
An Electronic Data Capture system (EDC) and Data Standard
agnostic solution that enables the pharmaceutical programming
community to develop Clinical Data Interchange Standards
Consortium (CDISC) Study Data Tabulation Model (SDTM) datasets
in R. The reusable algorithms concept in 'sdtm.oak' provides a
framework for modular programming and can potentially automate
the conversion of raw clinical data to SDTM through
standardized SDTM specifications. SDTM is one of the required
standards for data submission to the Food and Drug
Administration (FDA) in the United States and Pharmaceuticals
and Medical Devices Agency (PMDA) in Japan. SDTM standards are
implemented following the SDTM Implementation Guide as defined
by CDISC <https://www.cdisc.org/standards/foundational/sdtmig>.
