Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials: A prospective comparative study.

Claire Fougerou-Leurent Bruno LaviolleChristelle TualValérie VisseicheAurélie VeislingerHélène DanjouAmélie MartinValérie TurmelAlain RenaultEric Bellissant

Published in: British journal of clinical pharmacology (2019)

Targeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs.

Keyphrases

electronic health record
big data
clinical trial
study protocol
type diabetes
emergency department
data analysis
machine learning
adipose tissue
drug delivery
quality improvement
metabolic syndrome
artificial intelligence
adverse drug
deep learning
skeletal muscle
open label
glycemic control