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Top 10 Reasons for Using Dataset-JSON over Parquet for Data Exchange
November 2025This post, also shared on LinkedIn, is an article that addresses questions regarding raised in advance of the R/Pharma 2025 Dataset-JSON Workshop.
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Powering Standards With Code: The Role Of Open Source In CDISC 360i (article)
September 2025This post is a Clincal Tech Leader article based on a PHUSE SDE presentation on the same topic.
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Powering Standards with Code: The Role of Open Source in CDISC 360i (presentation)
July 2025This post is a presentation I delivered at the PHUSE SDE in West Windsor (NJ). It includes the slides and speaker notes.
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Enable and Automate: A Technical Roadmap Defining CDISC's Path to End-to-End Automation
Mar 2025This post is a PHUSE US Connect 2025 paper (DS05) that provides a high-level CDISC 360i Phase 1 Technical Roadmap.
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Results from the COSA Dataset-JSON Viewer Hackathon
Mar 2025This post provides insights and information on the recently completed COSA Dataset-JSON Viewer Hackathon.
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Managing Model Releases
November 2024This post shares some thoughts on release management for the models that form the basis of many new CDISC standards. Because software applications are needed to effectively use these models, factoring the impact of software maintenance into standards release planning will become increasingly important.
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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?
January 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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Using odmlib to Create ODM and Define-XML Tools in Python
May 2022This post is a PHUSE US Connect 2022 paper (OS01) that introduces the odmlib Python library for working with ODM and its extensions and spotlights using odmlib to generate a Define-XML v2.1 document.
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Generating HTML from Define-XML
April 2022This post describes 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.