sdtm-oak

Official

Automate SDTM domain creation from raw EDC data

AuthorRConsortium
Version1.0.0
Installs0

System Documentation

What problem does it solve?

This Skill automates the complex process of converting raw EDC/eCRF data into structured CDISC SDTM domains, saving time and reducing errors in clinical trial data management.

Core Features & Use Cases

  • Automatic SDTM Domain Derivation: Converts raw clinical data into SDTM-compliant formats for events, interventions, findings, and supplements.
  • Controlled Terminology Recoding: Applies CDISC controlled terminology to recode variable values, ensuring consistency and compliance.
  • Date Derivation and Formatting: Converts raw date/time data into ISO 8601 format for accurate analysis and reporting.
  • Use Case: A clinical researcher uses this Skill to quickly generate SDTM datasets from raw EDC data, simplifying the process of preparing data for regulatory submissions.

Quick Start

Derive the SDTM AE domain from the raw AE data file 'ae_raw.csv' using the sdtm-oak skill.

Dependency Matrix

Required Modules

sdtm.oakdplyrtibble

Components

scriptsreferences

💻 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: sdtm-oak
Download link: https://github.com/RConsortium/pharma-skills/archive/main.zip#sdtm-oak

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