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Issue Brief
Clinical Trials Offices: What’s New In Research Administration?
By Elaine Rubin, PhD, and Danielle Lazar, MA

Academic health centers continue to assess, change, and improve clinical research administration to advance science and better serve patients nationwide. In recent years, clinical trials offices (CTOs) have emerged within the academic health center research infrastructure to consolidate administrative activities related to clinical trials—from protocol development to billing compliance—and thus enhance institutional research capabilities. Management of clinical trial operations, viewed as critical to the sustainability and growth of the research enterprise, is among the challenging tasks for academic health center administrators because of the multitude of regulatory requirements and administrative procedures that must be addressed before, during, and after a clinical trial takes place.

To learn about the nature and scope of CTO operations, and as part of its ongoing analysis of clinical trials administration the Association of Academic Health Centers (AAHC) profiled eight member institutions in late 2008.

Institutions were selected based on responses to the AAHC Census, an AAHC survey of organization, governance, and operations at member institutions. Six institutions with a CTO and two without a designated office were selected. Of these eight institutions, four were public universities and four private, with 2007 research expenditures ranging from $10 million to more than $300 million.

Download the attached file to read the entire brief.

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