Dissertation/Thesis Abstract

Comparing site management of a NIH versus industry sponsored study: CTSN (surgical interventions for moderate ischemic mitral regurgitation) trial versus DEEP (Dual Epicardial Endocardial Protocol for Persistent and Longstanding Atrial Fibrillation) trial
by Ong, Jennifer, M.S., University of North Texas Health Science Center at Fort Worth, 2010, 93; 1489310
Abstract (Summary)

The management of a clinical trial requires the coordination of a number of tasks concurrently. Every study has its own individual difficulties and concerns that a research team must work around in order to get a study started and begin subject enrollment. The Baylor Research Institute is participating as a research site for both the CTSN and DEEP studies. Each study is funded by a different type of sponsor, which includes the National Institutes of Health and AtriCure. The two studies were followed from the early stage of site selection up until the point of subject enrollment. The CTSN and DEEP trials provided insight as to how to successfully manage the start-up of both types of studies, demonstrating the delays and difficulties that may arise as a clinical trial agreement approaches execution.

Indexing (document details)
Advisor: Gwirtz, Patricia
Commitee: DeHaas, Mary, Myers, Nanette, Reeves, Rustin
School: University of North Texas Health Science Center at Fort Worth
Department: Clinical Research Management
School Location: United States -- Texas
Source: MAI 49/04M, Masters Abstracts International
Subjects: Surgery, Health education, Health care management
Keywords: Clinical trial, Industry-sponsored, NIH-funded, Site management, Start-up phase, Study initiation
Publication Number: 1489310
ISBN: 978-1-124-50294-6
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