The Bariatric Surgery Clinical Research Consortium (BSCRC) is being established to """"""""facilitate coordinated clinical, epidemiological, and behavioral research in the field of bariatric surgery"""""""". The Consortium will include 4-6 collaborating clinical centers, a NIDDK Project Scientist and a Data Coordinating Center (DCC). This Consortium will work cooperatively to create a core information base, collected under a common protocol, on patients undergoing bariatric surgery and a non-surgical control group. The Consortium members will also participate in 1-2 clinical research projects each year. As the DCC, we will work with the BSCRC members to support all aspects of study design, study conduct, and data analysis for the central information core and each clinical research project. The DCC will develop a distributed data entry system and will maintain a secure, central database of clinical, laboratory, and surgical information, and serum and tissue sample inventories. The DCC will identify and contract with central laboratory (ies) and either coordinate with the Central NIDDK Biosample Repository or identify and contract with another repository. The DCC will develop safety and efficacy analysis plans and will prepare materials for presentations at BSCRC-related meetings, scientific conferences, and for publications and regulatory bodies. The DCC will coordinate all activities of the Consortium, including meetings and conference calls for the Executive Committee, Steering Committee, subcommittees, and presentations to the Data and Safety Monitoring Board. Finally, we will share data collected for the BSCRC with the wider scientific community and archive all data, study intervention materials, and coordinate archiving all specimens at the end of the study.
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