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.

抽象的 GLIA-CTN 行政单位将协调所有联合体的活动和财务，并制定总体规则与 RDCRN 和罕见疾病办公室 (ORD)/国家合作制定政策和程序儿童健康与发展研究所 (NICHD)。此外，该股还将充当行政部门联盟数据集成核心中心，集中 GLIA-CTN 收集数据的能力向相关利益相关者提供数据并向其提供数据，包括 RDCRN DMCC、患者倡导合作伙伴和行业合作者。行政部门还将负责 GLIA 的所有监管活动：持续评估现场生产力；监督所有项目，包括试点项目；和监督职业发展计划。此外，该部门将负责 NIH 和联邦合规性，例如实施监管活动、遵守 NIH 和联邦关于人类的政策主体保护、健康保险流通与责任法案 (HIPAA) 规定以及包容妇女、少数民族和儿童。行政单位内的实施细节如下如下所述，包括决策和管理的指挥系统、报告结构、沟通计划以及 GLIA 与 RDCRN 活动的整体整合。这组件描述了行政单位的关键角色以及 GLIA-CTN 的治理，使用数据集成核心、所有委员会以及与患者合作的机制倡导团体。