SDTM Advanced

Course Description

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
  • 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
Learning Outcomes

At the end of this course, a learner will be able to:

  • Describe how FAIR principles apply to CDISC standards
  • Model a selection of more complex data structures based on more detailed understanding of SDTM approaches, including relative timing variables, EX and EC, biospecimen events and lab-like data
  • Apply some more recently-developed variables to your studies, such as collected summary result
  • Analyze conformance rules, determine their likely origins, and by extension locate effective resources for implementation clarification
Continuing Education Units (CEUs)

Learners will receive 1.1 CEUs for successfully completing this course.

Successful Course Completion
  1. In order for a learner to successfully complete a course:
    1. An education representative or learner will complete training registration.
    2. A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    3. A learner will complete final course assessment with a score of at least 80% correct.
    4. A learner will complete summative assessment surveys
  2. Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
    1. 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.
    2. If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
    3. 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.
    4. 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.
Prerequisites
  • A working-level understanding of clinical research
  • Practical implementation experience with SDTM standards (at least one year experience is recommended)
Course Type

Private
Public
Virtual Classroom

Course Length

1-1/2 Days

Audience

Biostatistician
CRF Designer
Data Manager
Metadata Modeler
Nonclinical Study Personnel
Programmer
Standards Expert
Study Designer
Study Manager
System Architect
Technical Manager

Industry

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