Clinical Trial Schema Designer
If you're setting up clinical trials and need to generate CDISC-compliant schemas (SDTM/ADaM) from protocol documents, this automates a lot of the tedious mapping work between study design and regulatory data structures. It's aimed at the study setup phase when you're designing EDC systems or prepping for FDA submissions. The big caveat is that it only generates the design, you still need to implement it in a GxP-validated environment with proper controls. It works on protocols, not actual patient data, and can struggle with vague protocols or non-standard Phase 1 studies where variables don't fit cleanly into existing CDISC domains. Saves time on the grunt work but doesn't replace validation requirements.
- skills.sh installs
- 186
- GitHub stars
- 2
- last updated
- Aug 21, 2026
Install
$ npx -y skills add jorgealves/agent_skills --skill clinical-trial-schema-designer --agent claude-codeInstalls into .claude/skills of the current project.
Files
If you're setting up clinical trials and need to generate CDISC-compliant schemas (SDTM/ADaM) from protocol documents, this automates a lot of the tedious mapping work between study design and regulatory data structures. It's aimed at the study setup phase when you're designing EDC systems or prepping for FDA submissions. The big caveat is that it only generates the design, you still need to implement it in a GxP-validated environment with proper controls. It works on protocols, not actual patient data, and can struggle with vague protocols or non-standard Phase 1 studies where variables don't fit cleanly into existing CDISC domains. Saves time on the grunt work but doesn't replace validation requirements.
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- Repository
- github.com/jorgealves/agent_skills
- Categories
- AI & Agent Building, Data Science & ML
- First seen
- Jun 3, 2026
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