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edc-data-validation

Generate deterministic Python code for clinical data validation pipelines with range checks and SDTM compliance.

13|5|Updated May 4, 2026
Search Tags:#validation#sdtm#clinical-data#edc#cdisc#define-xml
One-click install
npx skills add https://github.com/awslabs/hcls-agent-skills --skill edc-data-validation
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: edc-data-validation
Source: https://github.com/awslabs/hcls-agent-skills/tree/main/skills/edc-data-validation
Command: npx skills add https://github.com/awslabs/hcls-agent-skills --skill edc-data-validation

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires pandas, lxml.

What problem does it solve?

This skill addresses the manual, error-prone nature of clinical data cleaning by providing a deterministic framework for validating EDC exports, checking data ranges, and ensuring cross-form consistency.

Core Features & Use Cases

  • Automated Validation: Perform range checks on vital signs and lab values, and verify cross-form consistency between AE, DS, and DM datasets.
  • Regulatory Compliance: Validate SDTM structures against CDISC rules and generate define.xml files for submission readiness.
  • Use Case: A data manager needs to verify that all adverse event dates occur after informed consent and that lab values fall within study-specific ranges; this skill generates the Python code to perform these checks instantly.

Quick Start

Invoke the edc-data-validation skill to generate a Python script that validates my current SDTM dataset against CDISC controlled terminology and checks for out-of-range vital signs.

Frequently Asked Questions about edc-data-validation

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

FAQPage Schema
How do I automate SDTM compliance checks and clinical data validation for EDC exports?▼

Automate clinical data validation by generating deterministic Python code that performs SDTM compliance checks, range checks, and cross-form consistency on EDC exports using pandas and lxml.

What is the best way to validate cross-form consistency between AE, DS, and DM datasets?▼

Validating cross-form consistency is achieved by running generated Python code that verifies data relationships across AE, DS, and DM datasets to ensure adverse event dates occur correctly after informed consent.

Can I generate define.xml files for regulatory submission preparation using Python?▼

Generate define.xml files for regulatory submission readiness using the lxml library within Python scripts that validate SDTM structures against CDISC controlled terminology and rules.

How do I perform range checks on vital signs and lab values for clinical data cleaning?▼

Perform range checks on vital signs and lab values by executing generated Python code that verifies clinical data falls within study-specific ranges, replacing manual and error-prone data cleaning processes.

Does this clinical data validation approach require specific Python dependencies?▼

This clinical data validation approach requires pandas for data manipulation and lxml for define.xml generation to ensure high-accuracy SDTM checks and regulatory submission preparation.

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