clinical-trial-schema-designer

Translate clinical protocols into CDISC-compliant SDTM/ADaM data schemas.

2|1|Updated Jan 25, 2026
One-click install
npx skills add https://github.com/jorgealves/agent_skills --skill clinical-trial-schema-designer
Or copy as Structured Prompt for Agent
Please help me install this Agent Skill.
Skill: clinical-trial-schema-designer
Source: https://github.com/jorgealves/agent_skills/tree/main/clinical-trial-schema-designer
Command: npx skills add https://github.com/jorgealves/agent_skills --skill clinical-trial-schema-designer

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

The Clinical Trial Schema Designer automates the creation of CDISC-compliant data structures (SDTM/ADaM) from clinical protocols, reducing manual data modeling effort and speeding up study design and submission preparation.

Core Features & Use Cases

  • Automated CDISC domain mapping from protocol inputs to standard domains (e.g., VS, DM, AE).
  • Schema generation aligned with FDA/PMDA standards for SDTM and ADaM.
  • Use Case: Design data ingestion pipelines for multi-source studies to streamline regulatory submissions.

Quick Start

Provide the protocol text and select the target CDISC standard (SDTM/ADaM/CDASH) to generate a ready-to-use data schema and mapping logic.

Frequently Asked Questions about clinical-trial-schema-designer

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I generate CDISC SDTM domains from a clinical trial protocol?

To generate CDISC SDTM domains from a clinical trial protocol, provide the protocol text to automatically map study data into standard domains like VS, DM, and AE, creating a ready-to-use schema.

What is the best way to automate ADaM schema creation for regulatory submissions?

Automating ADaM schema creation for regulatory submissions involves translating protocol inputs into FDA and PMDA-aligned data structures, reducing manual data modeling effort and speeding up submission preparation.

How do I convert clinical trial protocols into JSON data schemas?

To convert clinical trial protocols into JSON data schemas, the protocol text is processed to produce exportable JSON representations that align with CDISC standards for data integration pipelines.

Can I use clinical trial protocol text to map data for multi-source ingestion pipelines?

Yes, you can use clinical trial protocol text to map data for multi-source ingestion pipelines by automatically generating compliant data schemas that streamline study design and data integration.

Does automated CDISC schema generation support CDASH standards alongside SDTM and ADaM?

Yes, automated CDISC schema generation supports CDASH, SDTM, and ADaM standards, allowing you to select the target CDISC standard to generate the compliant data schema and mapping logic.

Why use automated domain mapping instead of manual data modeling for clinical trials?

Using automated domain mapping instead of manual data modeling for clinical trials reduces manual effort, minimizes structural errors, and significantly speeds up study design and regulatory submission preparation.