The SRA Symposium - College of Medicine
The SRA Symposium - College of Medicine
The SRA Symposium - College of Medicine
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Poster Abstract<br />
2005 <strong>Symposium</strong><br />
Annual Meeting <strong>of</strong> the Society <strong>of</strong> Research Administrators International<br />
Milwaukee, WI<br />
October 16-19, 2005<br />
Principal Author: Lisa M. Brown, MBA<br />
Author Affiliation: Center for Clinical Research<br />
University Hospitals <strong>of</strong> Cleveland<br />
Author Email: LisaM.Brown@uhhs.com<br />
Author Address: Center for Clinical Research<br />
University Hospitals <strong>of</strong> Cleveland<br />
11100 Euclid Avenue, LKS 1400<br />
Cleveland, Ohio 44106-7061<br />
Secondary Authors: David K. Ehlert, Center for Clinical Research,<br />
University Hospitals <strong>of</strong> Cleveland<br />
Philip A. Cola, M.A., Center for Clinical Research,<br />
University Hospitals <strong>of</strong> Cleveland<br />
Title: Clinical Research Study Budgeting Trends<br />
Abstract:<br />
Poster Abstracts<br />
<strong>The</strong> Center for Clinical Research at University Hospitals <strong>of</strong> Cleveland (UHC) provides legal and<br />
budget review, and administrative support, for over 360 clinical studies annually, which span<br />
twenty-four academic and clinical departments. Each study is governed by unique legal and fiscal<br />
terms. <strong>The</strong> budgets for these studies must not only reimburse for the fair market value <strong>of</strong> the<br />
medical services provided, but must also comply with numerous regulations designed to protect<br />
the interests <strong>of</strong> subjects enrolling in these studies.<br />
Many factors cause these budgets to differ. A review <strong>of</strong> 120 clinical research study agreements and<br />
budgets executed in 2004 was conducted across the various medical disciplines to understand<br />
where trends existed in clinical research budgets. <strong>The</strong>se budgets were reviewed to determine the<br />
effects <strong>of</strong> the differences in the per subject reimbursement: (i) by medical discipline; (ii) by the<br />
phase <strong>of</strong> the study drug/device development as determined by the FDA; (iii) <strong>of</strong> drug studies compared<br />
to the per subject reimbursement <strong>of</strong> device studies; and (iv) as a function <strong>of</strong> indirect rates<br />
provided by sponsors. <strong>The</strong> results <strong>of</strong> this sample reveal trends in budgeting that provide useful<br />
information to research administrators during clinical research study budget negotiations.<br />
2005 <strong>Symposium</strong> Proceedings Book 3
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