Journal article
Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study
Abstract
PURPOSE: To categorize, quantify and interpret findings documented in feedback letters of monitoring or auditing visits for an investigator-initiated, peer-review funded multicenter randomized trial testing probiotics for critically ill patients.
MATERIALS & METHODS: In 37 Canadian centers, monitoring and auditing visits were performed by 3 trained individuals; findings were reported in feedback letters. At trial termination, we performed …
Authors
Takaoka A; Zytaruk N; Davis M; Matte A; Johnstone J; Lauzier F; Marshall J; Adhikari N; Clarke FJ; Rochwerg B
Journal
Journal of Critical Care, Vol. 71, ,
Publisher
Elsevier
Publication Date
October 2022
DOI
10.1016/j.jcrc.2022.154094
ISSN
0883-9441