CDISC/SDTM

Course Overview

This course introduces the CDISC (Clinical Data Interchange Standards Consortium) framework and the SDTM (Study Data Tabulation Model) — the global standard for clinical trial data submission to regulatory authorities such as the FDA and PMDA. You will learn how to transform raw clinical trial data into SDTM-compliant datasets using SAS programming and understand the metadata and documentation requirements essential for regulatory compliance.

Learning Objectives

• Understand the CDISC standard framework (CDASH, SDTM, ADaM, Define.xml).

• Master the SDTM structure, domains, and variable-level metadata.

• Learn how to map raw datasets into SDTM format using SAS.

• Understand key domains (DM, AE, EX, VS, LB, MH, etc.) and their interrelations.

• Gain experience with SDTM Implementation Guide (SDTM IG) and Controlled Terminology (CT).

• Validate SDTM datasets using Pinnacle 21 Community.

Course Modules

Module 1: Introduction to CDISC Standards

• Overview of clinical trial data flow

• CDISC architecture: CDASH → SDTM → ADaM → Define.xml

• Global regulatory requirements (FDA, PMDA, EMA)

Module 2: SDTM Concepts and Structure

• SDTM dataset organization: General Observations, Findings, Events, Interventions

• Domain types and structure conventions

• Standard variables and naming rules

Module 3: Core SDTM Domains

• DM (Demographics)

• AE (Adverse Events)

• EX (Exposure)

• VS (Vital Signs)

• LB (Laboratory Tests)

• MH (Medical History)

Module 4: Implementation and Mapping

• Understanding CRF and raw data structure

• Deriving SDTM variables using SAS

• Creating RELREC and SUPPQUAL datasets

Module 5: SDTM Metadata and Validation

• Define.xml overview and metadata preparation

• Controlled Terminology and compliance

• Validation using Pinnacle 21

• Common SDTM compliance issues

Key Features

• 💻 Practical SAS mapping exercises

• 📘 Coverage of latest SDTM IG and CT standards

• 🧩 Real-world clinical trial examples

• ✅ Validation workflow using Pinnacle 21

Who Should Attend

• Beginners entering the clinical data programming field

• SAS programmers looking to specialize in SDTM mapping

• Clinical data managers and statisticians seeking CDISC knowledge

• Students in biostatistics or health data science

Duration

Approx. 10 hours (including practical mapping exercises and validation practice)

What You’ll Gain

By completing this course, you will be able to independently create SDTM-compliant datasets, document metadata, and ensure compliance with CDISC and regulatory standards — a foundational skill for any clinical data programmer.