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Administrative Unit for the GLIA-CTN

GLIA-CTN 行政单位

基本信息

批准号：
10266085
负责人：
Adeline Lucie Vanderver
金额：
$ 18.68万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10266085
关键词：
Advocacy Affect Agreement Alexander Disease Award Bylaw Caring Child Child Development Child Health Clinical Data Clinical Trials Clinical Trials Network Collaborations Collection Communication Communities Companions Computerized Medical Record Consent Forms Cost Sharing Data Data Collection Data Management Resources Decision Making Development Diagnosis Diagnostic Disease Ensure Evaluation Event Financial Support Foundations Health Health Insurance Portability and Accountability Act Home Individual Industry Industry Collaboration Infrastructure Institutes Institution Institutional Review Boards Intervention Lead Letters Medical center Metachromatic Leukodystrophy Mission Myelin Natural History Office of Administrative Management Onset of illness Patient Outcomes Assessments Patient advocacy Patients Pediatric Hospitals Philadelphia Pilot Projects Policies Procedures Productivity Program Development Rare Diseases Reporting Research Resources Schedule Site Structure Therapeutic Training United States National Institutes of Health Universities Utah Woman base career development clinical care clinical trial readiness data integration data management data warehouse experience faculty support federal policy feeding follow-up human subject protection improved industry partner leukodystrophy meetings member minority children novel open source patient advocacy group prospective pseudotoxoplasmosis syndrome relational database respiratory success support network tool

项目摘要

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.

摘要 GLIA-CTN行政单位将协调所有联合体活动和财务，并将制定一般与RDCRN和罕见疾病办公室（ORD）/国家儿童健康与发展研究所（NICHD）。此外，该股还将作为行政管理股，联合体数据集成核心中心，集中GLIA-CTN收集从相关的利益相关者，包括RDCRN DMCC，患者倡导合作伙伴和行业合作者。行政股还将负责GLIA的所有监管活动：对各地点的生产力进行持续评估;监督所有项目，包括试点项目;监督职业发展计划。此外，该单位将负责NIH和联邦的合规性，例如实施管理活动、遵守NIH和联邦关于人类健康政策受试者保护，健康保险流通和责任法案（HIPAA）规定，以及包括妇女、少数民族和儿童。行政组内的实施细节如下：包括决策和管理的指挥系统，报告这是一个非常重要的问题，它包括结构、沟通计划以及GLIA与RDCRN活动的整体整合。这组成部分描述了行政单位的关键作用，以及GLIA-CTN的治理，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。