COSA

CDISC Open Source Alliance

The CDISC Open-Source Alliance (COSA) supports, promotes, and sometimes sponsors open-source software projects that create tools for implementing or developing CDISC standards to drive innovation in the CDISC community.

COSA is directed by a Governance Board that evaluates projects for inclusion in the COSA Repository Directory, sets the project inclusion criteria, and determines what committees are needed to lead COSA activities. COSA activities may include communications or events like webinars, conference sessions, or hackathons. COSA seeks to collaborate with other open-source initiatives with similar missions.

The COSA Repository Directory lists repositories that are officially recognized by COSA as being open-source projects focused on implementing or developing CDISC standards to drive innovation in the CDISC community. All COSA projects must meet the inclusion criteria to be considered for inclusion in the Repository Directory.

Learn how you can leverage these COSA-approved tools to facilitate the implementation of CDISC standards in your systems.

  • Tplyr - a grammar of data format and summary, designed to simplify the creation of clinical safety summaries
  • Define-XML XLS Stylesheets can be used in the case of electronic submissions to regulatory agencies.
  • OpenStudyBuilder - a new approach to working with studies that once fully implemented will drive end-to-end consistency and more efficient processes - all the way from protocol development and CRF design - to creation of datasets, analysis, reporting, submission to health authorities and public disclosure of study information.

To drive innovative approaches to standards-based automation, CDISC has initiated the CDISC Open-Source Alliance (COSA), which supports, promotes, and sometimes sponsors open-source software projects that create tools for implementing or developing CDISC standards.

Learn the basics of how you can leverage the first COSA-approved tools to facilitate the implementation of CDISC standards in your systems.

  • TFL Designer – Ingests content from the CDISC Library to design study-specific analysis TFL shells, while producing machine-readable metadata that facilitates generation of analysis datasets and TFLs.
  • Visual Define-XML Editor - A WYSIWYG editor to help develop dataset specifications as a Define-XML document from the very beginning of the dataset development process.
  • Odmlib – A Python library that simplifies creating and processing ODM and its extensions, such as Define-XML