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@@ -3,8 +3,8 @@ Type: Package | |
Title: SDTM Data Transformation Engine | ||
Version: 0.1.0 | ||
Authors@R: c( | ||
person("Rammprasad", "Ganapathy", role = c("aut", "cre"), | ||
email = "[email protected]"), | ||
person("Rammprasad", "Ganapathy", email = "[email protected]", | ||
role = c("aut", "cre")), | ||
person("Adam", "Forys", role = "aut"), | ||
person("Edgar", "Manukyan", role = "aut"), | ||
person("Rosemary", "Li", role = "aut"), | ||
|
@@ -24,13 +24,16 @@ Authors@R: c( | |
person("Transition Technologies Science", role = c("cph", "fnd")) | ||
) | ||
Maintainer: Rammprasad Ganapathy <[email protected]> | ||
Description: An EDC-agnostic and data standard-agnostic SDTM data transformation engine | ||
that provides a framework for modular programming of SDTM in R. Powered by | ||
metadata and standard specification sdtm.oak can potentially automate the | ||
conversion of raw clinical data to SDTM through standardized mapping | ||
algorithms. SDTM is one of the required standards for data submission to | ||
the FDA (U.S.) and PMDA (Japan). SDTM standards are implemented following | ||
the SDTM Implementation Guide as defined by | ||
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>. | ||
Language: en-US | ||
License: Apache License (>= 2) | ||
|
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