This advanced course explores more complex topics not covered in the introductory SDTM classroom training, including standardized approaches for addressing these topics. Course topics are drawn from real-world examples identified by the CDISC user community and expert SDTM instructors. The topics include how and when to use OCCUR/FINDINGS ABOUT/SUPP structures; a forensic examination of Exposure (EX) and Exposure as Collected (EC); and the application of Associated Persons (AP) data with implementation examples.
- Course-level Learning Outcomes:
- At the end of this course, a learner will be able to apply defined SDTM principles to their implementation of studies.
- At the end of this course, a learner will be able to correctly use OCCUR, PRESP, REASND, and STAT.
- At the end of this course, a learner will be able to analyze timing data requirements for a study and implement a range of SDTM timing variables, including relative timing, reference variables and durations.
- At the end of this course, a learner will be able to analyze a variety of conformance rules, identify and explain their origins, and locate effective resources for implementation clarification.
- A working-level understanding of clinical research
- Practical implementation experience with SDTM standards (at least one year experience is recommended)
Audience: Experienced individuals involved in clinical research focused on SDTM implementation who wish to capture, represent, analyze, submit and/or publish their data using CDISC standards. Typically data managers, programmers, statisticians, and standards managers, but may include others.
Technology Service Provider