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Projects

Proposed Projects

Title

The Nomenclature of Clinical Data Quality

Abstract

A requirement of any field is a common language in which to express concepts and recommendations. Such a language does not exist for clinical data quality. Instead, a variety of terms are used for similar concepts, and similar terms are used to denote different concepts. This variability exists not only between the different fields (e.g., industry, academia, regulators) but within the fields as well. This project will survey the existing concepts and terminology, identify areas to increase consistency, and develop and recommend a common approach. Topics to be addressed include: What is the generic definition of “quality data?” How is quality defined in the context of the data lifecycle approach? How are errors defined? What differences in approach are reflective of differences in needs, and where would increased consistency be beneficial? What steps are required to achieve this increased consistency?

Deliverables

White paper to be placed at the disposal of the FDA and published for consideration by industry, academia, and other stakeholders in clinical data quality

Leader

TBD

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