• The Dataset-JSON API

  March 2024

  This post builds on my previous Dataset-JSON post and covers a draft Dataset-JSON API specification created during a COSA Hackathon.

• Why JSON for Datasets?

  Jan 2024

  This 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.

• No More XPT? Piloting New Dataset-JSON for FDA Submissions

  July 2023

  This post, originally published in Clinical Leader, introduces the PHUSE/CDISC/FDA Dataset-JSON as an alternative transport format for regulatory submissions pilot project.

• The CDISC Open Rules Engine (CORE): Open-Source Software for Clinical Research

  April 2023

  This post, originally published in Clinical Leader, introduces the CORE open-source software projects that provide the means to create and execute conformance rules.

• Generating HTML from Define-XML

  April 2022

  This post describes an an open-source, command-line method to convert Define-XML to HTML using the define2-1 stylesheet.

• Generating Define-XML v2.1 using odmlib

  August 2021

  This post highlights an example program that demonstrates how to generate a Define-XML v2.1 file using a metadata spreadsheet.

• Introducing odmlib

  June 2021

  This 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.