Impact of Monitoring Approaches on Data Quality in Clinical Trials.

Jeppe Ragnar Andersen Christoffer von SehestedInger ByrjalsenAnne Bo FollinAsger Reinstrup Bihlet

Published in: British journal of clinical pharmacology (2022)

These empirical data, directly comparing RBM with CM, suggest that RBM improves data quality regarding data-points of major importance to trial outcomes; efficacy and major safety. Overall, the RBM approach showed a correlation to reduced amount of data collection errors with major relevance for interpretation of study results and subject safety as well as reducing on-site monitoring and data cleaning resources.

Keyphrases

electronic health record
clinical trial
big data
type diabetes
emergency department
adipose tissue
metabolic syndrome
phase iii
open label