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How Reference Implementations Benefit Standards
July 2024This post introduces software reference implementations and how they contribute to standards development and adoption. As CDISC focuses on standards implementation, reference implementations become increasingly important.
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The Dataset-JSON API
March 2024This post builds on my previous Dataset-JSON post and covers a draft Dataset-JSON API specification created during a COSA Hackathon.
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Why JSON for Datasets?
Jan 2024This post explains the rationale for creating a dataset exchange format, Dataset-JSON, using JSON instead of alternative file formats and is motivated by the PHUSE/CDISC/FDA Dataset-JSON as Alternative Transport Format for Regulatory Submissions pilot project.
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No More XPT? Piloting New Dataset-JSON for FDA Submissions
July 2023This post, originally published in Clinical Leader, introduces the PHUSE/CDISC/FDA Dataset-JSON as an alternative transport format for regulatory submissions pilot project.
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The CDISC Open Rules Engine (CORE): Open-Source Software for Clinical Research
April 2023This post, originally published in Clinical Leader, introduces the CORE open-source software projects that provide the means to create and execute conformance rules.
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Generating HTML from Define-XML
April 2022This post describes an an open-source, command-line method to convert Define-XML to HTML using the define2-1 stylesheet.
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Generating Define-XML v2.1 using odmlib
August 2021This post highlights an example program that demonstrates how to generate a Define-XML v2.1 file using a metadata spreadsheet.
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Introducing odmlib
June 2021This post introduces the odmlib Python package that provides an object-oriented way to create and process ODM files as well as extensions like Define-XML.