SDTM Theory and Application
Course Applies To:
Upcoming Public Training Opportunities:
Can't make it to one of these events? CDISC also offers training on this standard via Private Training and Online Training.
This two-day course provides an introduction to and understanding of SDTM and the SDTM Implementation Guide for Human Clinical Trials. It covers the fundamental concepts underlying the standards, demonstrates how to apply those concepts in the creation of SDTMIG datasets, discusses the relationship to and primary expectations of regulators who review SDTMIG data, and the place of SDTMIG data in the continuum of CDISC standards from protocol to analysis. This 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
At the end of this course, you will be able to:
- Describe the SDTM model and implementation guide, the relationships between them and their relationships to other CDISC standards
- Use the SDTM model, implementation guide and controlled terminology to create SDTM-conformant datasets for a study
- Model custom variables and domains using the model, implementation guide and controlled terminology
Continuing Education Units (CEUs)
Learners will receive 1.4 CEUs for successfully completing this course.
Successful Course Completion
- In order for a learner to successfully complete a course:
- An education representative or learner will complete training registration.
- 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.
SDTM v1.4, v1.5, v1.6, v1.7 & SDTMIG v3.1.3, v3.2, v3.3
A basic understanding of relational database design and clinical data flow is helpful but not required.
Biostatistician, CRF Designer, Data Manager, Programmer
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider