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4-5 - Quality by Design: The Value of CRF Mapping 
April 17, 2016   10:45am - 11:45am
CNE credit for this article has expired.
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As medical records move from paper-based to electronic systems worldwide, the clinical research community struggles with the challenges of direct access to the electronic source for monitors, auditors and regulatory authorities. Alternative methods have evolved, such as source document worksheets, provision of "certified copies" of source and using CRFs as a source. This may result in duplication of effort by forcing personnel to review and print 'relevant' sources, increased risk of transcription errors and multiple conflicting 'sources' for a given data point. In the spirit of Quality by Design initiatives, sites and sponsors need to work together to ensure accurate, reliable data are obtained and reported. Explore the concepts of Quality by Design and Case Report Form mapping and explain the potential benefits of implementing these procedures early in your clinical studies. Participants should be prepared to engage in interactive discussion of this issue.

Learning Objectives:
  1. Describe the concept of Quality by Design (QBD).
  2. Identify at least three factors that contribute to data quality failures.
  3. Apply concepts of Case Report Form mapping to enhance data integrity and reduce data collection inconsistencies.

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