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SDTM Theory and Application for Human Clinical Trials (as of SDTM v1.7 & SDTMIGv3.3)

On Demand

Training Schedule Options (click on 'Read more...' to view all options)

The SDTM Theory and Application virtual training consists of 15 contact hours (5 scheduled days of live Zoom instruction at 3 hours each). The CDISC Education Team will email all registered participants a Zoom link one week prior to the start of training. 

NOTE: If you register for a training less than 48 business hours before the start date, please email to confirm your enrollment and receive the Zoom link.

See below for full breakdown of options: 

Option: Europe
Start Date: 6 September
Training Days: 6-10 September
(3-hour virtual sessions on Zoom)
Time: 11:00am-2:00pm
Central European Standard Time
Language: English
Location: online

Option: USA
*This course is part of the 2021 US Interchange.

Start Date: 18 October
Training Days: 18, 19, 22 October
(virtual sessions on Zoom)
MON 18 OCT; 12:00-17:00 US Eastern Time
TUE 19 OCT; 12:00-17:00 US Eastern Time
FRI 22 OCT; 12:00-17:00 US Eastern Time
Language: English
Location: online
Option: USA
Start Date: 25 October
Training Days: 25-29 October
(3-hour virtual sessions on Zoom)
Time: 11:00am-2:00pm
USA Eastern Time
Language: English
Location: online

Option: Japan
Start Date: 6 December
Training Days: 6-10 December
(3-hour virtual sessions on Zoom)
Time: 11:00am-2:00pm
Japan Standard Time
Language: Japanese
Location: online

*Trainings will be rescheduled or cancelled if minimum enrollment requirements are not met.

Course 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

This course roughly covers information in standards documentation as of SDTMv1.7 & SDTMIG v3.3. If there is a disparity of information, please ask the instructor during the training.

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