Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer: Coordinating and Data Management Center (CSCPDPC-CDMC)

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 DESCRIPTION (provided by applicant): A key to the success of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (Consortium) lies in effective communication and collaboration among scientists in multiple disciplines; strong study design for discovery and validation of biomarkers characterizing complex interactions between chronic pancreatitis (CP), diabetes mellitus (DM), and pancreatic cancer (PC) and evaluation of novel intervention strategies; and rigorous study execution of Consortium collaborative protocols. The overall aims of the proposed Coordination and Data Management Center (CDMC) are to (i) provide coordination of the Consortium in order to enhance communication and collaboration among Consortium investigators and with the larger scientific communities; (ii) provide scientific and statistical leadership for the Consortium in research strategy, study design approaches, and statistical and computational methods; and iii) coordinate Consortium collaborative studies. Under the direction of the Consortium Steering Committee (SC), the CDMC will 1) perform network coordination and promote collaborations among scientific investigators by providing support for Consortium meetings, SC, subcommittees, and Data Safety and Monitoring Board, developing and maintaining Consortium secured websites and listservs, and producing and maintaining all Consortium documents; 2) promote and develop proper study design approaches and analysis strategies for Consortium studies, provide statistical software to implement these strategies, provide statistical and computational support for Consortium collaborative studies, apply or develop novel statistical methods relevant to Consortium needs, in particular methods for dynamic prediction of PDAC risk in the Consortium cohort, methods for handling informative censoring in the Consortium cohort, and methods for group sequential biomarker evaluations; and 3) support Consortium collaborative studies by developing and maintaining the study data management system, working with Consortium investigators on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimens; and performing QA/QC and study evaluation; providing input on appropriate interpretation of study findings and reports; supporting the formation of distribution of Consortium biospecimen repositories; support preparations of documentations to FDA for Consortium INDs/IVDs, and providing a mechanism for rapid and routine information sharing among Consortium investigators and NIDDK/NCI staff.