SDTM Introduction

The Study Data Tabulation Model (SDTM) is the standard for organizing and formatting human clinical trial data for submission to regulatory authorities.

Purpose

SDTM provides:

• Consistent structure for clinical trial data
• Standardized naming conventions
• Regulatory compliance with FDA requirements
• Interoperability between systems and organizations

Key Concepts

Domains

SDTM organizes data into domains - logical groupings of related observations:

Variables

Each domain contains variables - individual data elements:

Controlled Terminology

Many variables require values from controlled terminology (CT):

• Standardized value lists
• Ensures consistency across studies
• Required for regulatory submissions

SDTM Structure

flowchart TB
    subgraph "SDTM Domain Classes"
        direction TB
        SP[Special Purpose<br/>DM, CO, SE, SV]
        INT[Interventions<br/>CM, EX, SU]
        EVT[Events<br/>AE, DS, MH]
        FIND[Findings<br/>LB, VS, EG, PE]
    end

    subgraph "Variable Types"
        ID[Identifiers<br/>STUDYID, USUBJID]
        TOPIC[Topic Variables<br/>--TERM, --TEST]
        TIMING[Timing Variables<br/>--STDTC, --ENDTC]
        QUAL[Qualifiers<br/>--SEV, --RES]
    end

    SP --> ID
    INT --> ID
    EVT --> ID
    FIND --> ID
    ID --> TOPIC
    TOPIC --> TIMING
    TIMING --> QUAL
    style SP fill: #4a90d9, color: #fff
    style INT fill: #50c878, color: #fff
    style EVT fill: #f5a623, color: #fff
    style FIND fill: #9b59b6, color: #fff

General Observation Classes

1. Interventions: Treatments applied to subjects
2. Events: Occurrences during study participation
3. Findings: Observations and test results

Variable Roles

Working with SDTM in Trial Submission Studio

Import Flow

1. Load source CSV data
2. Select target SDTM domain
3. Map source columns to SDTM variables
4. Handle controlled terminology
5. Validate against SDTM rules
6. Export to XPT format

Variable Requirements

• Required: Must be present and populated
• Expected: Should be present if applicable
• Permissible: Allowed but not required

Best Practices

1. Map identifiers first: STUDYID, DOMAIN, USUBJID
2. Use controlled terminology: For variables requiring CT
3. Follow naming conventions: Variable names, labels
4. Validate early: Catch issues before export

SDTM Versions

Trial Submission Studio currently supports:

• SDTM-IG 3.4 (current FDA standard)

Version History

Next Steps

• SDTM Domains - Domain reference
• SDTM Variables - Variable details
• Validation Rules - Compliance checking
• Controlled Terminology - CT reference