SDTM

Overview

This section contains examples demonstrating the creation of Study Data Tabulation Model (SDTM) domains using pharmaverse packages. SDTM is a CDISC standard for organizing and formatting data to streamline the regulatory review process.

The examples in this section primarily utilize the {sdtm.oak} package along with other pharmaverse tools to transform raw clinical trial data into SDTM-compliant datasets.

Examples

The following SDTM domain examples are available:

Demographics and Baseline Characteristics

  • DM (Demographics) - Learn how to create a Demographics domain including subject-level information such as age, sex, race, and study participation dates.

Clinical Events

  • AE (Adverse Events) - Create an Adverse Events domain to capture information about adverse events experienced by subjects during the study.

Findings

  • VS (Vital Signs) - Build a Vital Signs domain to record measurements such as blood pressure, heart rate, temperature, and other vital sign observations.

Getting Started

Each example includes:

  • Introduction and context
  • Step-by-step programming workflow
  • Code examples using pharmaverse packages
  • Expected output and validation checks

All examples use raw datasets from {pharmaverseraw} as input, ensuring consistency and reproducibility.

Before working with these examples, it’s recommended to review the {sdtm.oak} package documentation to understand key concepts such as algorithms, oak_id_vars, and mapping functions.