cdisc-compliance

Apply CDISC SDTM and ADaM standards to regulatory submissions.

13|5|Updated May 4, 2026

Search Tags:#fda #regulatory #sdtm #clinical-data #cdisc #adam

Ready to run

npx skills add https://github.com/awslabs/hcls-agent-skills --skill cdisc-compliance

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: cdisc-compliance
Source: https://github.com/awslabs/hcls-agent-skills/tree/main/skills/cdisc-compliance
Command: npx skills add https://github.com/awslabs/hcls-agent-skills --skill cdisc-compliance

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This skill resolves the complexity of aligning clinical trial data with CDISC SDTM and ADaM standards, preventing costly regulatory submission delays and P21 errors.

Core Features & Use Cases

Regulatory Decision Support: Provides expert guidance on complex domain mapping, SUPPQUAL usage, and define.xml metadata requirements.
Compliance Triage: Offers systematic frameworks for prioritizing data queries based on clinical impact and safety significance.
Use Case: Use this skill to validate your ADaM dataset design against FDA/PMDA requirements or to troubleshoot P21 errors during the final stages of a clinical study submission.

Quick Start

Invoke the cdisc-compliance skill to review the mapping logic for your oncology tumor assessment domain and ensure it meets current FDA submission standards.

Frequently Asked Questions about cdisc-compliance

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

FAQPage Schema

How do I resolve Pinnacle 21 errors for FDA submission datasets?▼

To resolve Pinnacle 21 errors for FDA submission datasets, use this skill to systematically triage data queries based on clinical impact and safety significance. It provides decision frameworks for troubleshooting compliance issues during final clinical study submission stages.

What is the best way to map clinical trial data to CDISC SDTM domains?▼

Mapping clinical trial data to CDISC SDTM domains requires expert reasoning for complex domain mapping and SUPPQUAL usage. This skill provides regulatory decision support to align your raw clinical data with current FDA and PMDA submission standards.

How do I generate define.xml metadata that meets FDA submission requirements?▼

Generating define.xml metadata for FDA submissions requires applying CDISC controlled terminology versioning and traceability rules. This skill offers expert guidance on define.xml metadata requirements to ensure regulatory submission data integrity.

Can I validate ADaM dataset design against PMDA compliance standards?▼

Yes, you can validate ADaM dataset design against PMDA compliance standards. This skill applies CDISC ADaM implementation rules to verify traceability and controlled terminology versioning for both FDA and PMDA regulatory submissions.

When should I use SUPPQUAL domains instead of standard SDTM variables?▼

Use SUPPQUAL domains instead of standard SDTM variables when handling non-standard data that cannot fit into existing CDISC domain structures. This skill provides decision frameworks for complex domain mapping and SUPPQUAL usage in regulatory submissions.

Why does controlled terminology versioning cause CDISC compliance failures?▼

Controlled terminology versioning causes CDISC compliance failures when dataset mappings use outdated or mismatched terminology codes. This skill ensures correct terminology versioning and traceability across SDTM and ADaM datasets to maintain regulatory submission data integrity.