Table 1

A sampling of CTSA site participation in Consortium process improvement strategies. This table lists challenges in clinical research management and the methods used by the CTSA Consortium (n = 60 sites) to address them.

Identified challenges in clinical research managementStrategic intervention teamInterventionCTSA participation [No. of sites/total sites at time of intervention (%)]
Lack of institutional commitment to efficiencyAppoint champions of changeImplement process improvement as guided by Consortium-wide studies, data, analysis, and recommendations51/55 (93%)
Lengthy protocol processingProtocol Review CommitteeTwo Consortium-wide studies of protocol processing times50/55 (91%)
Lengthy contract negotiationContract Review CommitteeTwo Consortium-wide studies of contract negotiation times42/46 (91%)
Multisite IRB review of identical multisite clinical protocolsReliance IRB Agreements GroupsRegional agreements member CTSA site (number of institutions) that signed agreement: Harvard (10), University of Wisconsin, Medical College of Wisconsin (Milwaukee) (5), The University of Texas (15), The University of California (4), Case Western (4), University of Rochester (16), University of Colorado (5), other sites (2, 3)>20/60 (>33%)
Delayed study start-up, inadequate enrollment of study participantsRecruitment GroupRecruitment model demonstrations: Rockefeller University, Washington University, Ohio State University, University of California–San Francisco, Virginia Commonwealth UniversityN/A
Web-based recruitmentResearchMatch54/55 (98%)
Delayed completion of studiesFeasibility GroupPending
Research participant surveyA quality and research experience assessment13/38 (34%)