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The DCRC Clinical Trials Core The Clinical Trials Core provides essential methodological and technical services and support for the DCRC. High quality biostatistical, data management and trial methodology support is critical for the successful conduct of clinical trials research. The purpose of the Core is to provide these services to the three proposed projects in the DCRC, to assist NESA investigators with these aspects of the development of new research initiatives and to help NESA develop the capacity to provide these services themselves as part of their progress towards becoming an independent research center. The Clinical Trials Core provides training and oversight to study coordinators/data managers in the implementation and conduct of each of the Projects including case report form development, data collection and entry, quality control and database management. This Core provides all aspects of biostatistical collaboration including study design, development of the analytic plan, development of randomization materials and procedures, performing analyses prescribed by the Data and Safety Monitoring Plan and other interim monitoring of the studies, preparation of analyses and interpretation of results, and collaboration on preparation of abstracts and manuscripts. The Clinical Trials Core coordinates all activities related to regulatory compliance, including development of informed consent procedures and documents, preparation of IRB applications and amendments, coordinating and documenting human subjects and HIPAA training and certification, and preparation of annual reports to the IRBs and NIH. The Core provides consultation to NESA investigators in biostatistics, trial methodology and data management/study coordination for research projects developed during the grant period. The Core also provides mentoring to NESA faculty, staff and students in the design and conduct of clinical research and assistance in the development of infrastructure to facilitate NESA's growth into an independent center of clinical research. Members of the Core bring extensive experience in all aspects of the design, coordination, conduct, analysis and reporting of clinical trials research. Co-Leaders: Roger Davis , ScD (1); Peter Wayne , PhD (NESA); Julie Buring , ScD (1) NESA Participants: Ellen Connors , MA, LMT (Research Coordinator) Other Participants: Andrea Hrbek (1) (Research Manager); Steven Schachter, MD (1) (Clinical Trialist); Anna Legedza, ScD (1) (Biostatistician); Hang Lee, PhD (2) (Biostatistician) Funding Agency - NCCAM---Grant # 5 U19 AT002022-03 Research Faculty and Staff
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