CDASH Advanced Topics

CDISC provides training on this standard via: Virtual Classroom Training (New!)

Interested in 'private, on-site' training for your team? Contact us today.

Course Description

Explore more complex topics drawn from real-world examples, including how and when to use Findings About (FA) in CDASH for events and interventions, 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 CDASH principles to studies
  • Correctly use YN, OCCUR, PRESP, REASND, and STAT
  • Analyze timing data requirements for a study and implement a range of CDASH timing variables, including relative timing, reference variables and durations

Pre-requisites

  • A working-level understanding of clinical research
  • Practical implementation experience with CDASH standards (at least one year experience is recommended)

Continuing Education Units (CEUs)

Learners will receive 0.7 CEUs for successfully completing this course.

Successful Course Completion

  1. 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
  2. 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.

Course Length

1 Day

Course Type

Private
Public
Virtual Classroom

Audience

Biostatistician
CRF Designer
Data Manager
Programmer

Industry

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