Upcoming Course Opportunities

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Course Description

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.

Learning Outcomes

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

  • Apply defined SDTM principles to their 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

  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 Length: 
1-1/2 Days
Course Type: 
Public, Private
Audience: 
Biostatistician, CRF Designer, Data Manager, Metadata Modeler, Nonclinical Study Personnel, Programmer, Standards Expert, Study Designer, Study Management, System Architect, Technical Manager
Industry: 
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider, Other