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

Advances in Nutrition
Kevin C MakiPenny M Kris-Etherton

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.

References

Oct 7, 2018·Acta Paediatrica·Claudia PeplowAnette-G Ziegler
Nov 18, 2020·Advances in Nutrition·Connie M WeaverLinda G Snetselaar

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Citations

Nov 18, 2020·Advances in Nutrition·Connie M WeaverPenny M Kris-Etherton
Nov 18, 2020·Advances in Nutrition·Alice H LichtensteinNirupa R Matthan

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Methods Mentioned

BETA
serum collection
blood draw
blood drawing
blood draws
blood collection
blood drawn
pregnancy test

Software Mentioned

TrialDB
OpenClinica
ORACLE CLINICAL
eClinical Suite
CLINTRIAL
RedCap
Access
R
Excel
SPSS Statistics

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