RESUMO
The Clinical and Translational Science Award (CTSA) Consortium Workshop was conceived as a venue to foster communication among academic medical centers (AMCs) in the development of methods to improve clinical research management. The consortium, comprised of 46 awardee sites as of 2009, many with multiple AMCs, is expected to expand to 60 sites when fully implemented. At the 2nd Annual CTSA Clinical Research Management Workshop held on June 22nd and 23rd , 2009, on the National Institutes of Health (NIH) campus, consortium members and potential CTSA sites gathered with stakeholders from private industry, the NIH, the Food and Drug Administration, and private research organizations, to formulate a plan to address challenges in clinical research management. Specific aims included improving protocol processing and sharing process improvement initiatives in the expectation that best practices will be implemented and improvements will be measured and reported. The findings presented at this workshop indicated significant variance in Institutional Review Board approval of protocols and contract execution by AMC and CTSA sites. Most represented marked delays compared to non-AMC sites and that, as a likely consequence, AMCs were later to enroll patients and/or meet enrollment targets compared to dedicated or professional sites.