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📊 What is CDISC SDTM & ADaM Training and Why Does it Matter?

CDISC SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are internationally recognised clinical trial data standards that define how clinical data is organised, validated, and reported. They are essential for regulatory submissions to agencies such as the FDA and EMA, ensuring that data from clinical trials is consistent, reliable, and compliant with global expectations.

In simple terms, learning CDISC SDTM & ADaM equips professionals with the skills to manage, structure, and analyse clinical trial data in a way that meets international standards.

The demand for expertise in clinical trial data standards is growing across the pharmaceutical, biotech, and clinical research industries. These standards are at the core of modern clinical research operations, making them vital for anyone aspiring to build a strong foundation in clinical data Programming

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Tools & Technologies in CDISC SDTM & ADaM Training

Our CDISC training provides practical exposure to the tools and processes that power today’s clinical trial workflows. You’ll gain expertise in:

  • SAS Programming for Clinical Trials - Building, validating, and analysing SDTM and ADaM datasets.
  • Clinical Data Standards - Applying CDISC-compliant frameworks for dataset creation and validation.
  • Statistical Programming Techniques - Generating outputs such as tables, listings, and figures (TLFs) for submissions.
  • Data Validation Practices - Checking consistency, handling discrepancies, and ensuring regulatory compliance.

This structured approach ensures you not only understand CDISC standards but also learn how to implement them effectively in real-world clinical data scenarios.

Why Choose Our CDISC SDTM & ADaM Training?

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Comprehensive Curriculum

Our CDISC SDTM & ADaM training covers everything from the fundamentals of clinical data standards to advanced dataset implementation. The curriculum ensures learners gain a strong foundation in SAS programming for clinical trials, CDISC compliance, and regulatory workflows.

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Hands-on Projects & Real-World Applications

Work directly with authentic clinical trial datasets to apply SDTM and ADaM concepts in practice. Through live exercises and case-based learning, you’ll gain the confidence to handle end-to-end clinical trial data standards and validation processes.

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Experienced Trainers

Learn from industry professionals with extensive experience in clinical data management courses, SAS programming, and CDISC standards. Their guidance ensures you stay aligned with real-world practices used in pharma, biotech, and CRO organisations.

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Future-Proof Skills

Stay ahead with training in emerging trends such as automation in data handling, advanced analytics, and AI-enabled approaches to clinical research training. These skills prepare you to adapt to the evolving landscape of clinical trial data management.

Course Highlights & Key Learning Modules

CDISC Overview
SDTM Overview – Part I and II
ADaM Introduction
SDTM & ADaM Assignments
CRF Annotation
SDTM – Mapping Specs Creation
SDTM – Dataset Development
SDTM – Dataset Validation
ADaM – Mapping Specs Creation
ADaM – Dataset Development
What You’ll Learn:
  • SDTM (v 3.4 IG) and ADaM (v 1.2 IG) Essentials: Gain in-depth understanding of the latest implementation guides, including how to create and validate variables across key datasets such as DM (Demographics), AE (Adverse Events), LB (Laboratory), ADSL (Subject-Level Analysis), ADAE (Adverse Events Analysis), and ADLB (Laboratory Analysis).
  • Working with ISO 8601 Dates: Learn to handle date and time variables using ISO 8601 standards, ensuring accuracy, consistency, and compliance in regulatory submissions.
  • Adverse Events & Lab Variables: Explore the hierarchy of adverse event variables and learn to effectively process paired laboratory variables, ensuring data is reliable and analysis-ready.
  • Dataset Structures: SDTM vs. ADaM: Review real-world examples of both SDTM and ADaM dataset structures, compare their purposes, and understand how they fit into the overall clinical data lifecycle.
  • Quality Control (QC) Checklist: Get introduced to a QC checklist designed to help assure data quality, integrity, and compliance with CDISC standards, making your work industry-ready.

Who Should Enrol?

Prerequisites

To get the most out of this training, learners should have:
  • Basic knowledge of Clinical Research and Clinical Trials
  • Understanding of SAS Programming (Base SAS certification preferred)
  • Interest in pursuing careers in Clinical Data Management, Biostatistics, or Statistical Programming

Take the Next Step in Clinical Data Analytics

The Whiteboard’s CDISC SDTM & ADaM Training is more than just a certification; it’s a specialised learning pathway for professionals looking to strengthen their expertise in clinical data programming and clinical trial data standards.

With expert mentorship, practical exposure, and a curriculum aligned with global best practices, you’ll gain the confidence to handle SDTM and ADaM datasets in compliance with FDA and EMA guidelines.

Ready to enrol? Start today and build a strong foundation in globally recognised CDISC standards.


Successful Stories

Eligibility

Candidates from the following background are welcome:

  • Life Sciences (M.Pharmacy, B.Pharmacy, M.Sc.)
  • Statistics (B.Sc., M.Sc.)
  • B.E / B.Tech (Biotechnology, Bioinformatics, Computer Science)
  • MBBS, BDS, BHMS, and BAMS

Any query regarding the course?

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