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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>.
Getting started
Browse package contents
Package details |
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| 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 [aut] (<https://orcid.org/0000-0001-5226-3441>), Kamil Sijko [aut] (<https://orcid.org/0000-0002-2203-1065>), 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@gene.com> |
| License | Apache License (>= 2) |
| Version | 0.1.1 |
| URL | https://pharmaverse.github.io/sdtm.oak/ |
| Package repository | View on CRAN |
| Installation |
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