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(Abbreviated Version) SDTM Theory and Application for Medical Devices Used in Humans

Begins 04 Nov 2018

In 2022, the SDTM Medical Devices course will be offered as an in-person, classroom training at the following locations: 

The Education Team can also organize a private virtual training for your organization; please contact for a quote.

Course Description (1/2-day course)

The Study Data Tabulation Model (SDTM) is a specification for the submission of pre-clinical, clinical and device data to the U.S. Food and Drug Administration in support of marketing applications. The SDTM Implementation Guide for Medical Devices (SDTMIG-MD) is used in conjunction with the SDTM and SDTMIG for Human Clinical Trials to support medical device submissions.

This course combines instruction on using the SDTM IG for Human Clinical Trials (the foundational SDTMIG) and device-specific domains and practices. It uses device-based examples to illustrate the key principles of the SDTM model and implementation guide, and covers the device domains in detail. Device-specific implementations of some core domain, such as AEs, are also included. 

Topics covered in the SDTM for Medical Devices course focus on subject-related data and device data, including:

  • SDTM Model
  • Demographics Model
  • General Observation Classes - Model
  • Timing and Grouping
  • Creating Custom Domains
  • General Observation Classes - Implemented
  • Findings About
  • Relationships
  • Device-specific Domains
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