STUDY DATA TABULATION MODEL (SDTM)

STUDY DATA TABULATION MODEL

In clinical research, standardized data submission is critical for regulatory approval. The Study Data Tabulation Model (SDTM), developed by the Clinical Data Interchange Standards Consortium (CDISC), is the global standard for organizing and formatting clinical trial data submitted to regulatory agencies such as the FDA and PMDA.
The SDTM program introduces learners to the structure, domains, and mapping rules of SDTM, preparing them to transform raw clinical data into standardized datasets ready for submission. This program is essential for clinical data managers, statistical programmers, and regulatory submission specialists aiming to work in FDA/EMA-compliant environments.

SIP – Self-Paced Online with Support

1. Course Duration: 4 weeks (100 hours)
2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).

   By completing this program, learners will:

2. Understand the purpose and importance of SDTM in regulatory submissions.
3. Learn the structure and metadata rules defined by CDISC.
4. Gain familiarity with SDTM domains (Demographics, Adverse Events, Concomitant Medications, Exposure, etc.).
5. Understand controlled terminology and compliance checks.
6. Perform raw-to-SDTM data mapping using case examples.
7. Learn about validation tools (Pinnacle 21, OpenCDISC).
8. Explore the role of SDTM in submission packages (Define.xml, SDRG).
9. Review real-world case studies of SDTM mapping and regulatory feedback.

1. Clinical Data Managers standardizing study data.
2. Statistical Programmers / SAS Programmers preparing regulatory datasets.
3. Biostatisticians involved in data analysis and submissions.
4. Regulatory submission staff handling CDISC-compliant datasets.
5. Career changers with data science/programming backgrounds entering pharma.

1. Build practical skills in CDISC SDTM mapping and validation.
2. Be job-ready for roles in clinical data management, statistical programming, and submissions.
3. Gain experience with real-world case mapping exercises.
4. Ensure compliance with FDA, EMA, and PMDA submission requirements.
5. Pathway to advanced training in ADaM (Analysis Data Model) and TLG (Tables, Listings, Graphs) programming.

1. Clinical Data Standards Specialist
2. CDISC SDTM Programmer
3. Statistical Programmer (Regulatory Submissions)
4. Clinical Data Manager (CDM – SDTM Expert)
5. Regulatory Data Compliance Analyst

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.