TY - JOUR
T1 - Perspective
T2 - Laboratory Considerations and Clinical Data Management for Human Nutrition Randomized Controlled Trials: Guidance for Ensuring Quality and Integrity
AU - Maki, Kevin C.
AU - Miller, Joshua W.
AU - Mccabe, George P.
AU - Raman, Gowri
AU - Kris-Etherton, Penny M.
N1 - Funding Information:
This project was funded by National Institutes of Health Clinical and Translational Science Awards to Tufts Clinical and Translational Science Institute (UL1TR002544), Indiana Clinical and Translational Sciences Institute (UL1TR002529), and Penn State Clinical and Translational Science Institute (UL1TR002014). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Publisher Copyright:
© 2020 The Author(s).
PY - 2021/1/1
Y1 - 2021/1/1
N2 - 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.
AB - 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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U2 - 10.1093/advances/nmaa088
DO - 10.1093/advances/nmaa088
M3 - Review article
C2 - 33200184
AN - SCOPUS:85102213164
VL - 12
SP - 46
EP - 58
JO - Advances in nutrition (Bethesda, Md.)
JF - Advances in nutrition (Bethesda, Md.)
SN - 2161-8313
IS - 1
ER -