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This course 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 for this course include:

  • 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

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 will complete formative assessment survey
    3. A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    4. A learner will complete final course assessment with a score of at least 80% correct.
    5. 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.

CDISC also offers this course through Private Training.

 

Course Applies To: CDASHIG v2.0, CDASH v1.0
Prerequisites: 

A basic understanding of the clinical data collection process is helpful to understanding the material presented.

Course Length: 
1 Day
Course Type: 
Public, Private, Licensed
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