The Study Data Tabulation Model (SDTM), developed by the Clinical Data Interchange Standards Consortium (CDISC), is a standardized framework for organizing and formatting clinical trial data. It is a critical part of regulatory submissions, designed to facilitate the efficient review and exchange of clinical data by regulatory agencies like the FDA and EMA.

A Study Data Tabulation Model (SDTM) course typically covers the following topics:

1. Introduction to SDTM

• Overview of CDISC and its importance in clinical trials
• SDTM fundamentals and structure
• Relationship between SDTM, ADaM, and SEND

2. SDTM Domains and Structure

• Understanding SDTM datasets (Demographics, Exposure, Adverse Events, etc.)
• Categorization of SDTM domains:
  • General Observation Classes
    • Interventions (e.g., EX, CM)
    • Events (e.g., AE, DS)
    • Findings (e.g., LB, VS)
  • Special-Purpose Domains (e.g., DM, CO)
  • Trial Design Domains (e.g., TA, TE, TV)

3. SDTM Variables and Metadata

• Controlled terminology and coding standards
• Core, expected, and permissible variables
• Understanding --TESTCD, --TEST, --CAT, --SCAT, --ORRES, --STRESC, --STRESN, --ORRESU, --STRESU

4. SDTM Mapping and Implementation

• Raw data to SDTM mapping process
• Handling missing data
• Using Define.xml and Study Data Reviewer’s Guide (SDRG)
• Common challenges and troubleshooting

5. SDTM Programming in SAS

• Data step and PROC SQL techniques for SDTM conversion
• Deriving standard SDTM domains
• Validation and compliance checks using Pinnacle 21

6. SDTM Validation and Submission

• SDTM compliance and regulatory guidelines (FDA/PMDA requirements)
• SDTM Validation rules
• Pinnacle 21 (OpenCDISC) for compliance checking

7. Hands-on Case Studies and Real-world Applications

• Practical exercises on mapping raw data to SDTM
• Building and validating SDTM datasets
• Common issues and solutions