Core A: Administrative Core

核心A：行政核心

基本信息

批准号：
10454252
负责人：
BENJAMIN L HANDEN
金额：
$ 116.44万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10454252
关键词：
Adoption Adult Advisory Committees Alzheimer&apos s Disease Alzheimer’s disease biomarker Ancillary Study Biological Markers Biometry Clinic Clinical Collaborations Collection Communication Data Development Down Syndrome Enrollment Equipment and supply inventories Funding Genetic Goals Good Clinical Practice Guidelines Individual Institutional Review Boards Kentucky Label Lead Michigan Modification Monitor Operations Research Participant Patient Recruitments Phenotype Physiological Policies Positron-Emission Tomography Principal Investigator Procedures Production Progress Reports Protocols documentation Publications Quality Control Radiopharmaceuticals Recommendation Reporting Research Research Personnel Research Project Grants Resources Risk Sampling Schedule Security Siblings Specimen Tissues Universities Work cohort data management meetings neuroimaging neuropathology non-genetic organizational structure outreach participant retention performance site recruit response translational research program

项目摘要

Administrative Core Abstract The Administrative Core will support the overall work of the Alzheimer Biomarker Consortium-Down Syndrome (ABC-DS), which includes eight Clinical Performance sites, seven Cores, three Research Projects and seven research subcontractors. Core staff will organize and coordinate activities and communication across each of these components. This will include providing administrative and budgetary support and monitoring, arranging and organizing meetings, and working closely with the ABC-DS Steering Committee to establish policies and procedures, delineate protocols, monitor recruitment, and track bio-specimen collection, dissemination and storage. In collaboration with the Neuroimaging Core, staff will coordinate all FDA regulatory requirements related to PET radiopharmaceutical production. Finally, the Administrative Core will provide support to the ABC- DS Publications and Ancillary Studies Committee and ABC-DS Bio-specimen Committee, organize annual NIA progress reports and twice-annual DSMB reports, and work closely with the Central IRB.

行政核心摘要行政核心将支持阿尔茨海默病生物标志物联盟-唐氏综合症的整体工作 (ABC-DS)，其中包括八个临床表现中心、七个核心、三个研究项目和七个研究分包商。核心人员将组织和协调各个部门的活动和沟通这些组件。这将包括提供行政和预算支持以及监测、安排组织会议，并与 ABC-DS 指导委员会密切合作，制定政策和程序、制定协议、监测招募并跟踪生物样本的收集、传播和贮存。工作人员将与神经影像核心合作，协调所有 FDA 监管要求与 PET 放射性药物生产相关。最后，行政核心将为 ABC 提供支持- DS 出版物和辅助研究委员会和 ABC-DS 生物样本委员会组织年度 NIA 进度报告和每年两次的 DSMB 报告，并与中央 IRB 密切合作。