CDASH Fundamentals and Implementation covers the CDASH Model v1.0, the CDASH Implementation Guide v2.0, and relevant Controlled Terminology. While the data fields are essentially the same in CDASHIG v2.0 as in v1.1, restructuring the standard into model and implementation guide makes it more robust, aligns it better with other CDISC standards, and facilitates data sharing and submission. The course covers navigating the documents, and using them to create data capture and storage structures for existing and custom data. It explains general observation classes, recommended variables, and several approaches to timing information. Using examples, it demonstrates numerous Case Report Form creation best practices, and discusses organizational best practices for CRF development. Finally, it walks in detail through how to implement CDASH in a simple study. There are numerous hands-on activities and opportunities to ask questions.
Learning Outcomes
At the end of this course, learners will be able to:
Describe the CDASH model and implementation guide and their purpose in data collection
Explain the relationship of CDASH to SDTM, Controlled Terminology and other CDISC standards
Describe the value of CDASH standards in the clinical research process
Select appropriate variables for a CRF based on core designations
Describe the role of Controlled Terminology in a CDASH CRF
Define, describe and identify Special Purpose, and General Observation Classes and associated data structures (domains)
Utilize best practices in CRF design
Apply the CDASH conformance rules
Use CDASH to create data capture and storage structures for existing standardized data and for custom variables and domains
Course Agenda
Module 1: CDASH in Context
Module 2: CDASH Model
Module 3: CDASH Implementation Guide
Module 4: Best Practices
Module 5: Conformance
Module 6: Applying CDASH to a Study
Continuing Education Units (CEUs)
Learners will receive 0.7 CEUs for successfully completing this course.
Required Downloads
Download the latest version of the documents prior to training:
Enrollment Confirmation
After enrolling in a virtual training, you will automatically receive a Confirmation Email with the following:
an order number
link to the CDISC Learning Management System (LMS)
You can immediately access the online training materials in the LMS.
Within 24 hours, you will be assigned to your specific virtual Zoom seminar event.
You will receive a Training Booking Confirmation Email from noreply_training@cdisc.org with the following:
event details (including a Zoom meeting link)
an iCal attachment
Please contact us if you do not receive these emails within 24 hours.
