Journal
ADVANCES IN NUTRITION
Volume 12, Issue 1, Pages 46-58Publisher
OXFORD UNIV PRESS
DOI: 10.1093/advances/nmaa088
Keywords
dietary interventions; human nutrition; clinical trials; best practices; biospecimens; laboratory methods; data management
Categories
Funding
- National Institutes of Health Clinical and Translational Science Awards [UL1TR002544, UL1TR002529, UL1TR002014]
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In this article, best practices for biospecimen collection, analysis, and clinical data management in human nutrition RCTs were outlined, aiming to improve data quality to support food and nutrition policies.
In human nutrition randomized controlled trials (RCTs), planning, and careful execution of clinical data collection and management are vital for producing valid and reliable results. In this article, we provide an overview of best practices for biospecimen collection and analyses, and for the fundamentals of clinical data management, including preparation and study startup; data collection, entry, cleaning, and authentication; and database lock. The reader is also referred to additional resources for information to assist in the planning and conduct of human RCTs. The tools and strategies described are expected to improve the quality of data produced in human nutrition research that can, therefore, be used to support food and nutrition policies.
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