SDTM Theory and Application
Upcoming Public 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
- In order for a leaner to successfully complete a course:
- An education representative or learner will complete training registration.
- A learner will complete formative assessment survey
- A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
- A learner will complete final course assessment with a score of at least 80% correct.
- A learner will complete summative assessment surveys
- Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
- 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.
- If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
- 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.
- 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.
Recommendation: A basic understanding of relational database design and clinical data flow is helpful but not required.