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

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 two-day SDTM for Medical Devices course focus on subject-related data and device data, and include:

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