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

Begins 11 Jul 2022
Available capacity: 30

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

The SDTM Theory and Application virtual training consists of 17.5 contact hours (5 scheduled days of live Zoom instruction at 3.5 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 schedule options:

Region: Japan 日本
21, 22, 24, 25, 28 February
(No class on 23 Feb - Emperor's Birthday)
09:00 - 12:30
Japan Standard Time (Japanese)

SDTM Theory and Application:
Region: EU
9 - 13 May
09:00 - 12:30
Central European Summer Time (English)

SDTM Theory and Application:
Region: Japan 日本
4 - 8 July
13:00 - 16:30  
Japan Standard Time (Japanese)

Region: China 中国
11 - 15 July

13:00 - 16:30  
China Standard Time (Mandarin)

Region: India
18 - 22 July

13:00 - 16:30  
India Standard Time (English)

SDTM Theory and Application:
Region: US
12 - 16 September
09:00 - 12:30
US Eastern Time (English)

*Registration ends at 5:00pm EST (17:00) one business day prior to the training start date.

*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.

Date: 11 Jul 2022
Start Time: 13:00
End Time: 16:30
Instructor : Zhijun Wei
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