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CDASH Implementation

Upcoming Training Opportunities:

 

The CDASH standard describes the basic data collection fields that are common to all therapeutic areas and all types of clinical research. This full-day course will provide attendees with an overview of the key concepts from the CDASH standard. The course also includes in-depth implementation information for all of the CDASH domains, with hands-on exercises and a post-course assessment.

Course content includes:

  • Intro to CDASH in the World of CDISC Standards
  • Foundational Principles of the CDASH Standard
  • Best Practices When Using CDASH
  • CDASH Conformance Rules
  • Using CDASH to Expand your Library
  • Putting it All Together for a Study

Learning outcomes addressed in this course include:

  • Access and use the CDASH documentation
  • Apply the foundational principles to study development and conduct
  • Assess conformance of study materials to the CDASH standards

Successful Course Completion

  1. In order for a leaner 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.
Current Course Material Used: 
CDASH v2.0, SDTMIG v3.2, SDTM v1.4, AE & VS CDASH Training Datasets
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, Online, Licensed
Audience: 
Biostatistician
CRF Designer
Data Manager
Programmer