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Compliance In Focus
Posted by John Lehmann on Mon, Jun 30, 2014

The Other Side of Clinical Research: Research Administration

Advancements are always being sought out to improve clinical research administration, withResearch Administration better patient care as the ultimate goal.  According to an article on The Association of Academic Health Centers website, the current administrative landscape for clinical trials is exceedingly complex.  Many interdependent functions are spread across the research enterprise, which often results in the establishment of administrative structures and small bureaucracies operating as separate, unconnected silos that lack policies or formal procedures for communications and interaction.  The article goes on to explain that the life cycle of a clinical research project involves stakeholders from different realms of academic health center administration who possess various skills and knowledge about clinical research or business functions.

In recent years, a more focused consideration has been made to try and pinpoint the weaknesses within these systems, and the lack of uniformity revealed amongst these entities and within these functions has lead to this need for a fix.  Part of that fix has been the development of Clinical Trial Offices (CTOs).  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.  This concept is seen as one that can work, however what was discovered in the several institutions examined by the AAHC, is that the CTOs in place exhibited varied characteristics and combined some, but not all, of the processes associated with clinical trials administration and management.  According to the findings, in many of these institutions, the CTOs operated in parallel with existing infrastructure causing a redundancy in the processes.

It’s clear that we have some ways to go before we get to where we want to be on the Research Administration landscape.  What are your thoughts on where we’re heading in this area?

Photo Credit: International Information Program (IIP)

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Topics: Research Administration, Clinical Trial Offices, Clinical Research


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