Upcoming Course Opportunities
Can't make it to one of these events? CDISC also offers training on this standard via Private Training.
The SDTM Advanced Topics training explores topics beyond SDTM Theory and Application, including complex SDTM modeling. Course topics are drawn from real-world examples identified through the standard development process as well as by the CDISC user community and our expert SDTM instructors. Training topics include:
- Timing Variables
- Advanced Controlled Terminology Implementation
- Findings About and Outcomes of OCCUR
- The EX and EC Domains
- Changes in severities
- Linking Data
- Conformance Rules and Requirements
- Associated Persons
- Biospecimen Events
- Lab-related data
- --CAT & --SCAT Variables
- Drug Classes
- The 'Collected Summary Result Type' Variable
At the end of this course, a learner will be able to:
- Apply defined SDTM principles to the implementation of studies.
- Correctly use OCCUR, PRESP, REASND, and STAT.
- Analyze timing data requirements for a study and implement a range of SDTM timing variables, including relative timing, reference variables and durations.
- Analyze a variety of conformance rules, identify and explain their origins, and locate effective resources for implementation clarification.
Continuing Education Units (CEUs)
Learners will receive 1.1 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.
- A working-level understanding of clinical research
- Practical implementation experience with SDTM standards (at least one year experience is recommended)