ADMINISTRATIVE AND CLINICAL RESEARCH

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The goals of the core are to provide all projects with centralized leadership, administrative, biostatistical and clinical research support. The Adminstrative component will be responsible for integrating all components of the PPG and overseeing progress, so that the research objectives are being met. To achieve these goals the core will arrange internal group meetings including the monthly investigator meeting, executive committee meetings and invited research lectures. It will provide assistance to each project and core leader with budgetary issues and will also oversee the overall fiscal and budgetary management of the program. This core will also co-ordinate oversight of the PPG by convening meetings of the Internal and External Advisory Boards and implementing their recomendations. The goals of the clinical research component of this core are to provide all projects with centralized clinical trial support and provide an infrastructure of personnel and services that will adequately support such research. Core services will be provided in regulatory affairs, study coordination, quality assurance and control and data safety monitoring. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including submissions to the IRB, IBC, FDA, and NIH/ORDA and annual reports. This core has extensive experience with IND submission and currently supports over 25 IND studies. The Quality Control (QC) program will ensure that standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are accurately defined and being followed. The QA program will undertake audits after the first patient is enrolled on a study and then randomly to ensure that the studies are being conducted according to Good Clinical Practices. The core will also co-ordinate data monitoring by the Data Review Committee which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies in this program. The Biostatistics component will provide comprehensive and centralized support that integrates the biostatistical activities of the research projects in this PPG. It will coordinate and manage the statistical activities of the program to ensure that investigators have ready access to biostatistical consultation; provide biostatistical expertise in study planning and conduct of clinical trials and preclinical validation experiments, coordinate data management activities and provide comprehensive support for data analysis including safety/toxicity monitoring, interim reviews of data, final analysis, and reporting. The Biostatistics Core personnel will incorporate sound experimental principles in study planning and development, implement a coordinated data management system, and facilitate provision of timely and high-quality statistical analysis and data interpretation.