sdtm.oak (version 0.1.0)

sdtm.oak-package: sdtm.oak: SDTM Data Transformation Engine

Description

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.

Author

Maintainer: Rammprasad Ganapathy

Authors:

• Adam Forys

• Edgar Manukyan

• Rosemary Li

• Preetesh Parikh

• Lisa Houterloot

• Yogesh Gupta

• Omar Garcia

• Ramiro Magno (ORCID)

• Kamil Sijko (ORCID)

• Shiyu Chen

Other contributors:

• Pattern Institute [copyright holder, funder]

• F. Hoffmann-La Roche AG [copyright holder, funder]

• Pfizer Inc [copyright holder, funder]

• Transition Technologies Science [copyright holder, funder]

See Also

Useful links:

• https://pharmaverse.github.io/sdtm.oak/

• Report bugs at https://github.com/pharmaverse/sdtm.oak/issues/