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trial-design-domains

Generate SDTM Trial Design domains TS, TV, TE, and TA from clinical protocol data.

Updated Aug 27, 2026
Search Tags:#validation#protocol#generate#clinical-research#SDTM#trial-design
One-click install
npx skills add https://github.com/siddharthchauhan/ETL --skill trial-design-domains
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: trial-design-domains
Source: https://github.com/siddharthchauhan/ETL/tree/main/sdtm_pipeline/deepagents/skills/trial-design-domains
Command: npx skills add https://github.com/siddharthchauhan/ETL --skill trial-design-domains

SYSTEM DOCUMENTATION & REQUIREMENTS

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.

Frequently Asked Questions about trial-design-domains

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

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

You can generate SDTM trial design domains by inputting clinical protocol data to automatically create TS, TV, TE, and TA records. This ensures your SDTM design remains directly aligned with protocol specifications for data modeling.

What is SDTM cross-domain validation for trial design domains?▼

SDTM cross-domain validation checks consistency across ARM, ETCD, and Visit mappings within the TS, TV, TE, and TA domains. It enforces domain consistency and provides linking guidance to ensure protocol-driven SDTM alignment.

Can I use protocol data to automate TS, TV, TE, and TA record creation?▼

Yes, you can automate TS, TV, TE, and TA record creation directly from protocol data sources. This converts a clinical protocol into a complete SDTM design package ready for domain generation, review, and mapping.

What's the best way to ensure protocol-driven SDTM mapping across trial domains?▼

The best way to ensure protocol-driven SDTM mapping is to generate trial design domains directly from protocol data and run built-in cross-domain consistency validations. This enforces domain consistency and integrates with validation tooling.

Do I need structured clinical protocol data to build SDTM trial design domains?▼

Yes, you need a clinical protocol data source to build SDTM trial design domains. The skill uses this input to automate the creation of TS, TV, TE, and TA records and enforce protocol-driven consistency across domains.

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