Understanding USDM: Digital Design and Schedule of Activities

CDISC provides public training on this standard via: Virtual / In-Person Classroom Training 

Interested in a private Virtual training for your team? Contact us today.

Course Description

In this engaging training, you'll build a foundational understanding of the USDM structure and explore its practical applications through real-world use cases. This training will walk you through key areas of the USDM, such as study setup, activity scheduling, intervention planning, and integration with downstream systems like EDC. Attendees who successfully complete the training will receive a Certificate of Achievement and digital badge to showcase their new expertise!

Learning Outcomes

You will be able to:

  • Recognize the structure and constraints of USDM based on the model and Controlled Terminology
  • Demonstrate how the Schedule of Activities (SoA) can be covered in USDM
  • Translate USDM-related information into study design documents in various formats (e.g., M11)
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:
    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.
Course Type

Private
Public
Virtual Classroom

Course Length

1 Day