The Clinical Research Core will promote excellence in research for all human subjects research and provide support to all COBRE III investigators as needed. Comprehensive support services will be available through this core for all aspects of participant recruitment, regulatory submissions, study coordination, compliance, reporting of adverse events, data management and biostatistical support. The Clinical Research Core will play a central role for all COBRE III research and will promote focused and efficient interactions among studies resulting in a well-integrated center that is greater than the sum of its individual parts.
The specific aims of the Clinical Research Core are to provide: 1. Support to optimize the recruitment and retention of participants for studies of osteoarthritis prevention and treatment 2. Support for management of all data resources. Direct support for design of data collection forms, as well as data entry and management, will be provided to research investigators 3. Support for biostatistical needs. Biostatisticians will provide consultation regarding statistical analysis, as well as grant and manuscript preparation. In the case of pilot studies, support will also be available for research design and estimation of sample sizes. The Clinical Research Core will be under the direction of Dr. Lynn Snyder-Mackler (Director of the Clinical Research Core). Dr. Snyder-Mackler, working with Dr. Kurt Manal (COBRE III Program Coordinator), will provide overall administrative direction and coordination of the Clinical Research Core. Or. Snyder-Mackler has worked closely with Dr. Buchanan, the COBRE Director, in the planning of the overall structure of the COBRE III and has specifically worked with the individual project Pi's in the planning of their respective research projects involving human subjects. Dr. Snyder-Mackler will provide oversight of the Clinical Research Core's staff, including the Research Coordinators, Data Managers and Biostatisticians. Given the nature of the work to be done by the Clinical Research Core, formal communication processes will be required. The plan will be for Dr. Snyder-Mackler to meet with all members of the core on a biweekly basis to discuss ongoing studies, as well as potential pilot projects which will require core services. All Clinical Research Core members will also be encouraged to participate in all meetings of the COBRE III program, as appropriate. The Clinical Research Core will serve all projects, as well as the pilot projects. The Clinical Research Core will be directly involved in participant recruitment/retention efforts, data management and biostatistical consultation. Depending on the nature of the pilot studies that are funded through the COBRE III, appropriate support in the areas of recruitment, data management and biostatistical consultation will be available, particularly in the realm of research design and sample size estimation. In all, the coordination of clinical research support services in the context of this Clinical Research Core will be a vital component of the COBRE III program here at the University of Delaware. This Core will ensure efficient use of shared resources and maximize productivity of investigators to carryout ongoing studies and to develop new research questions into competitive grant proposals.
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