• Managing Model Releases

  November 2024

  This 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.

• How Reference Implementations Benefit Standards

  July 2024

  This 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.

• 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?

  January 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.