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

On Demand

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

Course Schedule

Name: SDTM Theory & Application for Medical Devices

Date/Time: MON 18 OCT; 13:00-17:00 US Eastern Time 

Location: Online (part of the US Interchange)

Instructor: CDISC Authorized Instructor

Course Language: English

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