Administrative Unit for the GLIA-CTN

摘要 GLia-CTN行政股将协调所有财团的活动和资金，并将制定一般 与RDCRN和罕见疾病办公室(ORD)/国家合作制定的政策和程序 儿童健康与发展研究所(NICHD)。此外，该股将担任行政部门。 财团数据集成核心中心，集中GLia-CTN的收集能力 来自相关利益相关者并向其提供数据，包括RDCRN DMCC、患者权益倡导合作伙伴和 行业合作者。行政股还将负责法律援助办公室的所有监管活动： 对现场生产率进行持续评价；监督所有项目，包括试点项目；监督 职业发展计划。此外，该股将负责NIH和联邦合规， 如实施管理活动、遵守美国国立卫生研究院和联邦人权政策 主体保护、《健康保险可携带性和责任法案》(HIPAA)规定，以及 包括妇女、少数群体和儿童。行政股内部的执行细节如下 并包括决策和管理的指挥链、报告 结构、沟通计划以及全球研究组与区域疾病控制和预防网络活动的全面整合。这 构成部分描述了行政单位的主要作用，以及法律信息和通信技术网络的治理情况， 使用数据集成核心、所有委员会和与患者协作的机制 倡导团体。

Abstract The GLIA-CTN Administrative Unit will coordinate all consortium activities and finances and will set general policies and procedures in collaboration with the RDCRN and Office of Rare Disorders (ORD)/ National Institutes of Child Health and Development (NICHD). In addition, the Unit will serve as the administrative center for the Data Integration Core of the Consortium, to centralize the ability of the GLIA-CTN to collect from and deliver data to relevant stakeholders, including the RDCRN DMCC, patient advocacy partners and industry collaborators. The Administrative Unit will also be responsible for all regulatory activities of GLIA: ongoing evaluation of productivity at sites; oversight of all projects including pilot projects; and oversight of the career development program. In addition, the Unit will be responsible for NIH and federal compliance, such as implementation of regulatory activities, observance of NIH and federal policies regarding human subject protections, Health Insurance Portability and Accountability Act (HIPAA) stipulations, and the inclusion of women, minorities and children. Details of implementation within the Administrative Unit are described below and include the chain of command for decision-making and administration, the reporting structure, the communication plan, as well as for the overall integration of GLIA with RDCRN activities. This component describes the key roles of the Administrative Unit, as well as the governance of the GLIA-CTN, the use of a Data Integration Core, all committees and the mechanisms for collaboration with the patient advocacy groups.