Aug | India Day Training

Prior to CDISC India Day, CDISC will offer a two-day SDTM Theory and Application training session, sponsored by Pfizer, at Courtyard by Marriott in Chennai, allowing attendees to deepen their expertise and gain practical knowledge. 

Due to high demand in India, we will be operating a ballot system for a FREE seat to this training.

Questions? Contact the CDISC Education Team

Training Schedule

SDTM Theory and Application (2-day Training):
20-21 August 2026 - Day 1: 09:00-18:00 / Day 2: 09:00-13:00 India Standard Time (includes one-hour lunch break)

Certificates of Achievement will be available for attendees who successfully complete this training and pass the assessment. Please bring your laptop to fully participate in the training.


Training Location

Company name: Courtyard by Marriott, Chennai
Address: 564 Anna Salai, Teynampet Chennai - 600018, Tamil Nadu, India
Training Room: Sutlej
Training Sponsored by Pfizer


Instructor

Instructor:
Sandeep Sawant


Based in India, Sandeep plays a key role in the formation of the CDISC user group there. He is the winner of multiple academic honors and possesses a master's degree in statistics. He has worked in data standards, statistical programming, and biostatistics for about 20 years. He is currently an Associate Director of Data Standards and Governance at Syneos Health. He has given numerous trainings and workshops on SDTM and ADaM in a variety of industry forums in India and other countries. Several industry forums have published some of his most important contributions. In 2015–16, he finished his CDISC Fellowship, and he co-wrote CFAST TAUG, which treats breast, prostate, and malaria.


Training Description

The Study Data Tabulation Model (SDTM) is a specification for structuring pre-clinical and clinical data to support interoperable and reusable data sharing, including submissions to the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in support of marketing applications.

This course consists of:

  • A detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design.
  • A discussion of common implementation issues.
  • Exercises including the annotation of CRFs and the creation of datasets that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide for clinical data.

Note: This course roughly covers information in standards documentation as of SDTMv1.7 & SDTMIG v3.3.


Learning Outcomes

At the end of this course, learners will be able to:

  • Describe the SDTM model and implementation guide and the relationships between them.
  • Model timing variables correctly for relative, actual, planned and time point data.
  • Identify Findings About candidate data and model them correctly.
  • Construct accurate relationship datasets for non-standard variables and linkages across datasets.

Training Modules

Module 1: Introduction to CDISC
Module 2: SDTM Basics: Model
Module 3: SDTM Basics: Implementation Guide
Module 4: Demographics Model
Module 5: General Observation Classes
Module 6: Timing Variables
Module 7: Creating Custom Domains
Module 8: Interventions and Events Domains
Module 9: Findings and Related Timing
Module 10: Findings About
Module 11: Relationships and Grouping
Module 12: Trial Design
Module 13: Special Purpose Domains
Module 14: Dataset and Variable Metadata
Module 15: Conformance
Module 16: Summary

SDTM Training Ballot System

Due to high demand in India, we will be operating a ballot system for a FREE seat to this two-day SDTM training in India, sponsored by Pfizer.

How the Ballot Works

1

Submit one ballot

Fill in your name and work email address. One entry per person — duplicates will be removed.

2

Ballot closes on 10 July

Entries are accepted until Friday, 10 July 2026. No entries are accepted after the deadline.

3

Names are drawn

13 seats are allocated, one per unique organization. Drawn applicants are notified by email — seats cannot be transferred.

Submit Your Ballot