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trial-design-domains

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Streamline SDTM Trial Domain design.

Data & Analytics#validation#protocol#generate#clinical-research#SDTM#trial-design
Authorsiddharthchauhan
Version1.0.0
Installs0

System Documentation

What problem does it solve?

Trial design domains provide a structured blueprint to capture the planned SDTM domains (TS, TV, TE, TA) from a protocol, enabling consistent data modeling, protocol-aligned mappings, and efficient downstream templating.

Core Features & Use Cases

  • Generate the TS, TV, TE, and TA domains directly from protocol data to ensure protocol-driven SDTM design.
  • Validate cross-domain consistency (ARM/ETCD/Visit mappings) and provide linking guidance across TS, TV, TE, TA.
  • Use case: Convert a clinical protocol into a complete SDTM design package ready for domain generation, review, and mapping.

Quick Start

Use the trial-design-domains skill to generate TS, TV, TE, and TA from a protocol data source and run the built-in consistency validations.

Dependency Matrix

Required Modules

None required

Components

Standard package

💻 Claude Code Installation

Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.

Please help me install this Skill:
Name: trial-design-domains
Download link: https://github.com/siddharthchauhan/ETL/archive/main.zip#trial-design-domains

Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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