Rationale and Development of a Data Coordinating Center to Support the Type 1 Diabetes in Acute Pancreatitis Consortium.
Rationale and Development of a Data Coordinating Center to Support the Type 1 Diabetes in Acute Pancreatitis Consortium.
复制标题
支持1型糖尿病急性胰腺炎联盟的数据协调中心的基本原理和发展。
DOI：
10.1097/mpa.0000000000002075
复制
发表时间：
2022-07-01
期刊：
影响因子：
2.9
通讯作者：
Chinchilli, Vernon M.
中科院分区：
文献类型：
--
作者：
Dyer, Anne-Marie;Baab, Kendall Thomas;Merchlinski, Aimee;Valencia-Moulton, Paula A.;Holmes, Beth R.;Pichardo-Lowden, Ariana;Serrano, Jose;Laughlin, Maren R.;Chinchilli, Vernon M.
关键词：
multicenter studyproject managementscientific coordinationmanual of proceduresbiostatisticsdata managementAEadverse eventAPacute pancreatitisCCclinical centerCRFcase report formDCCdata coordinating centerDMSdata management systemDREAMDiabetes RElated to Acute pancreatitis and its MechanismsDSMBData and Safety Monitoring BoardICFinformed consent formMOPmanual of proceduresNIHNational Institutes of HealthPIprincipal investigatorPSU- Penn State UniversityQCquality controlSAEserious adverse eventSCsteering committeesIRBsingle institutional review boardT1DAPCType 1 Diabetes in Acute Pancreatitis Consortium
数据协调中心（DCC）是任何多中心研究项目的关键成员，对于1型糖尿病急性胰腺炎联盟（T1DAPC）来说尤其如此。我们描述了T1DAPC DCC如何通过其在项目管理、行政管理、财务管理、法规遵从性、科学协调、数据管理、研究计算和生物统计以及促进科学出版方面的经验和专业知识来支持该联盟。发展协调委员会的矩阵管理系统在管理其所有职责方面极为有效。T1DAPC生命周期的前16个月致力于开发其第一个方案，标题为与急性胰腺炎相关的糖尿病及其机制（DREAM），解决机构审查委员会和监管部门的问题，开发T1DAPC数据管理系统，并为临床中心工作人员提供培训和认证。由于其努力，DCC是T1DAPC能够在2022年1月启动DREAM研究招募的主要贡献者。
A Data Coordinating Center (DCC) is a critical member of any multi-center research undertaking, and that is especially true for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). We describe how the T1DAPC DCC supports the consortium via its experience and expertise in project management, administration, financial management, regulatory compliance, scientific coordination, data management, research computing, and biostatistics and in facilitating scientific publications. The DCC’s matrix management system has been extremely effective in managing all of its responsibilities. The first 16 months in the life of the T1DAPC have been dedicated to the development of its first protocol, titled Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM), addressing the institutional review board and regulatory components, developing the T1DAPC data management system and providing training and certification of Clinical Center staff. As a result of its efforts, the DCC was a major contributor to the T1DAPC being able to initiate recruitment for the DREAM study in January 2022.