SDTM Advanced Topics

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.
  • Prerequisites:
    • 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.


Course Length

1-1/2 Days

Course Type

Private
Public

Audience

Industry

Academic Institution
BioTech
Clinical Laboratory
Consulting
CRO
Government
Healthcare Provider
Medical Device
NPO
Pharmaceutical
Technology Service Provider
Other