Perspective: Laboratory Considerations and Clinical Data Management for Human Nutrition Randomized Controlled Trials: Guidance for Ensuring Quality and Integrity

Kevin C. Maki, Joshua W. Miller, George P. McCabe, Gowri Raman, Penny M. Kris-Etherton

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)46-58
Number of pages13
JournalAdvances in nutrition (Bethesda, Md.)
Volume12
Issue number1
DOIs
StatePublished - Feb 1 2021

All Science Journal Classification (ASJC) codes

  • Food Science
  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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