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SDTM Theory and Application for Medical Devices

Upcoming Training Opportunities:

 

 

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

Exercises are included in numerous places to reinforce the material.

 

The course merges the foundational SDTM 2-day course and the Medical Devices ½-day course, and duplicates much of the material in both.  Students should take either the 2-day medical device SDTM course OR the combination of the 2 day SDTM course plus the ½-day devices course, but not all three.

 

 

 

Alternative Option: ½-day SDTM for Medical Devices

 

This ½-day course focuses almost exclusively on the medical device domains and the associated implementation guide.  Topics include:

  • Context and scope of the SDTMIG-MD
  • The types of devices covered by the standard
  • Differences in use of terminology between drug and device studies
  • Full review of the 7 device domains
  • Representing device & subject data in different domains

A case-based, hands-on exercise reinforces the use of the seven device domains. This course does not cover the basics of SDTM, and assumes the student already has this knowledge.

 

Successful Course Completion

  1. In order for a leaner to successfully complete a course:
    1. An education representative or learner will complete training registration.
    2. A learner will complete formative assessment survey
    3. A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    4. A learner will complete final course assessment with a score of at least 80% correct.
    5. A learner will complete summative assessment surveys
  2. Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
    1. If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
    2. If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
    3. If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
    4. If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.
Current Course Material Used: 
SDTM v1.4, SDTMIG v3.2, SDTMIG Medical Devices v1.2
Prerequisites: 

A basic understanding of clinical data flow and relational database design is helpful but not required.

Course Length: 
2 Days
Course Type: 
Public, Private, Licensed
Audience: 
Biostatistician
CRF Designer
Data Manager
Programmer