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成功的关键（联合体）在于多学科科学家之间的有效沟通和协作;强有力的研究设计，用于发现和验证表征慢性胰腺炎（CP）、糖尿病（DM）和胰腺癌（PC）和新的干预策略的评估;和严格的研究执行联盟合作协议。拟议的协调和数据管理中心（CDMC）的总体目标是：（一）协调联合会，以加强联合会研究人员之间以及与更大的科学界的沟通与合作;（二）在研究战略、研究设计方法以及统计和计算方法方面为联合会提供科学和统计领导;（三）协调合作研究。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和监测委员会提供支持，开发和维护联合体安全网站和邮件列表，以及制作和维护所有联合体文件，执行网络协调并促进科学研究者之间的合作; 2）促进和发展适当的研究设计方法和分析策略，为联盟研究，提供统计软件，以实现这些战略，为联盟合作研究提供统计和计算支持，应用或开发新的统计方法相关的联盟的需求，特别是用于动态预测联合体组群中PDAC风险的方法、用于处理联合体组群中的信息性删失的方法和用于组序贯生物标志物评估的方法;和3）通过开发和维护研究数据管理系统，与联盟研究者合作进行研究设计、方案开发、数据表，学习手册;协调和监测研究;跟踪标本;进行QA/QC和研究评价;为研究结果和报告的适当解释提供输入;支持联盟生物标本储存库的分布;支持为联盟IND/IVD准备向FDA提交的文件，并为联盟研究者和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.