This repository contains the comprehensive documentation website for the OpenStudyBuilder project. The OpenStudyBuilder is an open-source project for clinical study evaluations that drives end-to-end consistency and more efficient processes - from protocol development and CRF design to dataset creation, analysis, reporting, submission to health authorities, and public disclosure of study information.
📖 Visit the Documentation Site
The documentation is automatically built and deployed via GitHub Pages whenever changes are pushed to this repository.
| Type | Description |
|---|---|
| Project Type | COSA project (CDISC Open Source Alliance) |
| Owner | Novo Nordisk A/S |
| Contact | OpenStudyBuilder@gmail.com 📅 Regular Open Sessions planned 💬 Slack: Join OpenStudyBuilder |
| First Release | Q3 2022 |
| Documentation | Project Homepage |
| Main Repository | openstudybuilder-solution |
| Programming Languages | Python, Cypher (Neo4j), JavaScript (Vue.js) |
| Licenses | Components with MIT and GPLv3, documentation CC-BY-4.0 |
| CDISC Standards | CDISC CT, CDASH, SDTM, ADaM with ODM-XML and Define-XML |
| Users | Standards Governance, Study Designer, Standards Management, Trial Management, Medical Writing, Data Management, Biostatistics, Medical & Science, Clinical Pharmacology |
This documentation site is built using MkDocs with the Material theme.
We welcome contributions to improve the OpenStudyBuilder documentation! Here's how you can help:
- Fork this repository
- Create a feature branch:
git checkout -b feature/improve-documentation
- Make your changes to the Markdown files in the
docs/folder - Test locally using
mkdocs serve - Submit a pull request with a clear description of your changes
- Use clear, concise language
- Include examples and code snippets where helpful
- Follow the existing file naming conventions (
guide_*.md,info_*.md) - Add images to
docs/img/and reference them with relative paths - Update navigation in
mkdocs.ymlif adding new pages
Unless otherwise stated, the content of this documentation website is licensed under the
Creative Commons Attribution 4.0 International License (CC BY 4.0).
Copyright © 2026 Novo Nordisk A/S, Danish company registration no. 24256790
This means the content may be shared and adapted for any purpose, including commercial use, provided that appropriate credit is given to Novo Nordisk A/S and a link to the license is included.
📧 Questions? Contact us at OpenStudyBuilder@gmail.com or join our Slack community!