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

 描述(申请人提供)：慢性胰腺炎、糖尿病和胰腺癌研究联盟(联盟)的成功关键在于多学科科学家之间的有效沟通和合作；为发现和验证表征慢性胰腺炎(CP)、糖尿病(DM)和胰腺癌(PC)之间复杂相互作用的生物标记物而进行的强有力的研究设计，以及对新的干预策略的评估；以及联盟合作协议的严格研究执行。拟议的协调和数据管理中心(CDMC)的总体目标是：(1)为财团提供协调，以加强财团调查人员之间以及与更大科学界的沟通和合作；(2)在研究战略、研究设计方法以及统计和计算方法方面为财团提供科学和统计方面的领导；(3)协调财团的协作研究。在联合体指导委员会(SC)的指导下，CDMC将1)通过为联合体会议、SC、小组委员会和数据安全与监测委员会提供支持，开发和维护联合体安全的网站和列表服务器，以及制作和维护联合体的所有文件，执行网络协调和促进科学调查人员之间的合作；2)为联合体研究促进和制定适当的研究设计方法和分析战略，提供统计软件以实施这些战略，为联合体协作研究提供统计和计算支持，应用或开发与联合体需求相关的新统计方法，特别是联合体队列中PDAC风险的动态预测方法、联合体队列中处理信息性审查的方法和群体序贯生物标记物评估方法；以及3)通过开发和维护研究数据管理系统，与联合体调查人员合作进行研究设计、方案制定、数据表格和研究手册，支持联合体合作研究；协调和监测研究；跟踪标本；以及进行QA/QC和研究评估；为研究结果和报告的适当解释提供投入；支持形成联盟生物样品储存库的分发；支持向FDA准备联盟INDS/IVDS的文件，并为联盟调查人员和NIDDK/NCI工作人员之间的快速和常规信息共享提供机制。

 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.