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.

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

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

This 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.

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

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

This post demonstrates how to create a simple ODM file using odmlib.

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.