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

On Demand

Training Dates Breakdown

Date listed in select options below is first day of that SDTM Theory and Application training. Full breakdown below:

Option 22 Mar :: Training Days 22-26 Mar,  12-3pm New York Time (USA ET)

Option 5 Apr :: Training Days 5-9 Apr, 11-2pm Beijing Time

Option 17 May :: Training Days 17-21 May, 11-2pm Brussels Time

Option 21 Jun :: Training Days 21-25 Jun, 11-2pm New York Time (USA ET)

Option 5 Jul :: Training Days 5-9 Jul, 11-2pm Tokyo Time

Option 6 Sep :: Training Days 6-10 Sep, 11-2pm Brussels Time

Option 20 Sep :: Training Days 20-24 Sep, 11-2pm Beijing Time

Option 25 Oct :: Training Days 25-29 Oct, 11-2pm New York Time (USA ET)

Option 6 Dec :: Training Days 6-10 Dec, 11-2pm Tokyo Time

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 two-day 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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