cdisc-standards

Map clinical data to CDISC SDTM domains using SDTM-IG v3.4.

Updated Aug 27, 2026
One-click install
npx skills add https://github.com/siddharthchauhan/ETL --skill cdisc-standards
Or copy as Structured Prompt for Agent
Please help me install this Agent Skill.
Skill: cdisc-standards
Source: https://github.com/siddharthchauhan/ETL/tree/main/sdtm_pipeline/deepagents/skills/cdisc-standards
Command: npx skills add https://github.com/siddharthchauhan/ETL --skill cdisc-standards

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This skill provides deep understanding of CDISC SDTM standards, including SDTM-IG guidelines and controlled terminology, to enable accurate domain mapping, data validation, and consistent SDTM transformations.

Core Features & Use Cases

  • SDTM-IG v3.4 knowledge to guide domain mapping, variable requirements, and domain classes.
  • Controlled terminology adherence for precise code mappings across DM, AE, LB, VS, CM, EX, and related domains.
  • Protocol interpretation guidance to align study design, visit schedules, epochs, inclusion/exclusion criteria, and screening outcomes with SDTM structures.

Quick Start

Map a sample dataset to the SDTM DM and AE domains using SDTM-IG guidance. Validate USUBJID, --SEQ, and CT mappings against the standard.

Frequently Asked Questions about cdisc-standards

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

FAQPage Schema
How do I map clinical data to SDTM domains using CDISC standards?

To map clinical data to SDTM domains, you apply CDISC SDTM-IG v3.4 guidelines for domain structures, variable requirements, and domain classes to transform raw datasets accurately. This ensures standardized domain mapping and terminology usage.

What CDISC controlled terminology is required for SDTM domain validation?

CDISC controlled terminology provides exact code mappings required for SDTM domain validation across DM, AE, LB, VS, CM, and EX domains. Enforcing these standard validation checks ensures compliance with USUBJID and SEQ rules.

How does protocol interpretation align with SDTM domain structures?

Protocol interpretation aligns with SDTM domain structures by translating study design elements like visit schedules, epochs, and inclusion criteria into standardized data mapping templates. This ensures clinical trial data matches the planned study design.

Can I validate USUBJID and SEQ rules against CDISC SDTM-IG v3.4?

Yes, you can validate USUBJID and SEQ rules by applying standard validation checks based on CDISC SDTM-IG v3.4. This process enforces exact terminology usage and verifies that clinical data transformations comply with required CT mappings.

What are the limitations of using CDISC standards for clinical data transformations?

The limitation of using CDISC standards for clinical data transformations is that this knowledge base focuses strictly on SDTM-IG v3.4, meaning it may not support newer CDISC implementation guides or specialized domain extensions outside its current scope.