Journal article
Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis
Abstract
BACKGROUND: The objective of this report is to describe the roles, responsibilities and recommendations of a 3-member Event Adjudication Committee (EAC) and a 5-member data monitoring committee (DMC) for a prospective multicenter observational study of critically ill patients with renal insufficiency examining the bioaccumulation and bleeding risk associated with dalteparin thromboprophylaxis.
METHODS: The EAC reviewed bleeding events to …
Authors
Cook D; Sinuff T; Zytaruk N; Rabbat C; Lee A; O'Donnell M; Thabane L; Linkins L; Treleaven D; Patel R
Journal
Journal of Critical Care, Vol. 24, No. 2, pp. 168–175
Publisher
Elsevier
Publication Date
June 2009
DOI
10.1016/j.jcrc.2009.01.010
ISSN
0883-9441