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Study Designer

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A free, open-source web tool to design clinical research protocols on health data warehouses.

Why?

Designing research protocols on health data warehouses (HDWs) is still largely a manual, free-form exercise: protocols written in prose, variables tracked in spreadsheets, medical codes picked without shared governance. This heterogeneity limits reproducibility, hinders multicentric studies, and makes it harder to share code between teams.

Study Designer offers a graphical interface to author formalized, machine-readable protocols aligned with OMOP-CDM — to strengthen access to clinical data warehouses and standardize secondary research.

To dig deeper into HDWs and study design, see the Understanding health data warehouses resource series.

Features

  • General information, context, and objectives (Markdown editor)
  • Population definition with composable inclusion / exclusion criteria (AND / OR / NOT)
  • Concept sets management (OHDSI-compatible)
  • Variable definitions with temporal anchors and time windows
  • Statistical analysis plan (Table 1, regressions, survival, etc.)
  • Sample size, missing data, regulatory information
  • Schema mapping (OMOP CDM v5.3 / v5.4, MIMIC-III / IV presets)
  • Auto-generated SQL preview from criteria + schema mapping
  • Multi-format export: JSON, ZIP, Word, Excel, Markdown
  • Bilingual: French (default) and English

The application runs entirely in the browser — projects are stored in localStorage, with no server, no account, no tracking.

Tech stack

  • Astro 5 (static site generation)
  • React 19 for the interactive app (client:load)
  • Tailwind CSS v4 via @tailwindcss/vite
  • TypeScript, Radix UI, Monaco editor, dnd-kit
  • Deployed on GitLab Pages

Local development

npm install
npm run dev      # http://localhost:4321
npm run build    # build static site to dist/
npm run preview  # preview the production build

Node 20+ is required.

Deployment

The site is deployed as a static bundle on GitLab Pages via .gitlab-ci.yml. Update astro.config.mjs (site field) with the final deployment URL when known.

Author

Created by Boris Delange, Hospital-University Assistant Physician in medical informatics at Rennes University Hospital and the University of Rennes.

License

This software is distributed under the CeCILL-B free software license — a permissive French license, similar in spirit to BSD, compatible with international standards. The full license text is available in the LICENSE file.

Contributions, feedback and bug reports are welcome.

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