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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>.

Version: 0.1.1
Depends: R (≥ 4.2)
Imports: admiraldev (≥ 1.1.0), dplyr (≥ 1.0.0), purrr (≥ 1.0.1), tidyr (≥ 1.2.0), rlang (≥ 1.0.2), tibble (≥ 3.2.0), vctrs (≥ 0.5.0), stringr (≥ 1.4.0), assertthat, pillar, cli
Suggests: knitr, htmltools, lifecycle, magrittr, rmarkdown, spelling, testthat (≥ 3.1.7), DT, readr
Published: 2024-11-12
DOI: 10.32614/CRAN.package.sdtm.oak
Author: Rammprasad Ganapathy [aut, cre], Adam Forys [aut], Edgar Manukyan [aut], Rosemary Li [aut], Preetesh Parikh [aut], Lisa Houterloot [aut], Yogesh Gupta [aut], Omar Garcia [aut], Ramiro Magno ORCID iD [aut], Kamil Sijko ORCID iD [aut], Shiyu Chen [aut], Pattern Institute [cph, fnd], F. Hoffmann-La Roche AG [cph, fnd], Pfizer Inc [cph, fnd], Transition Technologies Science [cph, fnd]
Maintainer: Rammprasad Ganapathy <ganapathy.rammprasad at gene.com>
BugReports: https://github.com/pharmaverse/sdtm.oak/issues/
License: Apache License (≥ 2)
Copyright: F. Hoffmann-La Roche AG, Pattern Institute, Atorus Research LLC and Transition Technologies Science sp. z o.o.
URL: https://pharmaverse.github.io/sdtm.oak/
NeedsCompilation: no
Language: en-US
Materials: README NEWS
CRAN checks: sdtm.oak results

Documentation:

Reference manual: sdtm.oak.pdf
Vignettes: Algorithms & Sub-Algorithms (source, R code)
Conditioned Data Frames (source, R code)
Creating an Findings SDTM domain (source, R code)
Creating an Interventions SDTM domain (source, R code)
Converting dates, times or date-times to ISO 8601 (source, R code)
Path to Automation (source, R code)

Downloads:

Package source: sdtm.oak_0.1.1.tar.gz
Windows binaries: r-devel: sdtm.oak_0.1.1.zip, r-release: sdtm.oak_0.1.1.zip, r-oldrel: sdtm.oak_0.1.1.zip
macOS binaries: r-release (arm64): sdtm.oak_0.1.1.tgz, r-oldrel (arm64): sdtm.oak_0.1.1.tgz, r-release (x86_64): sdtm.oak_0.1.1.tgz, r-oldrel (x86_64): sdtm.oak_0.1.1.tgz
Old sources: sdtm.oak archive

Linking:

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These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.