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SDTM Theory and Application

Upcoming Training Opportunities:

 

 

The Study Data Tabulation Model (SDTM) is a specification for the submission of pre-clinical and clinical data to the U.S. Food and Drug Administration 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

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, SDTM Exercises
Prerequisites: 

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

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