The Clinical Operations and Regulatory Affairs (CORA) Core provides the Weill Cornell four COPD SCCOR clinical projects the infrastructure and expertise to conduct clinical research projects that follow the regulations and guidelines of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Institutional Review Board (IRB) and Office for Human Research protections (OHRP). Included in the CORA Core are four components: (1) Clinical Operations;(2) Regulatory Affairs;(3) Monitoring;and (4) Data Management and Analysis. The Clinical Operation component is the major interface of the CORA Core with the study participants and investigators, providing services to carry out the clinical study in compliance with all regulations and guidelines under established standard operating procedures. The Clinical Operation component is also the major interface between the investigators and the local oversight groups, including the IRB and the General Clinical Research Center (GCRC). The Monitoring component functions to verify that all functions of the CORA Core are appropriate. The Data Management and Analysis component processes collected and verified data, enters the data into databases, and analyzes the data using appropriate statistical methods. The Regulatory Affairs component is the interface of the CORA Core with federal agencies for oversight of clinical research studies. In addition the Regulatory Affairs component provides periodic reports to the Weill Cornell Data Safety and Monitoring Board to provide additional oversight to clinical studies. The CORA Core also participates in the Weill Cornell COPD SCCOR Clinical Research Skills Development Core (Core E), providing training in Clinical Operations/Regulatory Affairs. The CORA Core will play an important role in helping the investigators to implement and conduct the four clinical projects. Finally, the CORA Core will play a central role in assisting the investigators in preparing, submitting and getting all regulatory documents to the IRB and the Weill Cornell Data Safety Monitoring Board (DSMB) throughout the yr 01-05 study period.
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