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Core B: Clinical Resource Core

核心 B：临床资源核心

基本信息

批准号：
10282002
负责人：
Nicolaas Ida Bohnen
金额：
$ 23.73万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10282002
关键词：
Age Attention Biometry Classification Clinic Clinical Clinical Data Clinical assessments Cognition Collaborations Common Data Element Consensus Data Data Analyses Data Collection Databases Decision Making Diagnostic Eligibility Determination Enrollment Evaluation Fostering Foundations Functional disorder Gait Gender Goals Health Insurance Portability and Accountability Act Infrastructure Institutional Review Boards Magnetic Resonance Methods Michigan Motor Movement Disorders National Institute of Neurological Disorders and Stroke Neuropsychology Newsletter Online Systems Parkinson Disease Patients Phenotype Policies Population Positron-Emission Tomography Process Quality Control Registries Regulation Research Personnel Research Subjects Resolution Resources Standardization Universities cholinergic cohesion cohort data exchange data integrity data management experience follow up assessment follow-up human subject in vivo instrument neuroimaging operation organizational structure recruit repository symposium

项目摘要

CORE B: SUMMARY/ABSTRACT The Clinical Resource Core (CRC; Core B) will provide support for human subjects Projects I and III of the University of Michigan (U-M) Udall Center through recruitment, enrollment, and detailed clinical assessment of Parkinson disease (PD) subjects and age- and gender-matched control (NC) subjects. A unique feature of the proposed U-M Udall Center is that it will leverage the unique deeply clinical and neuroimaging phenotyped PD population from our previous Udall Center (09/2014-08/2020). The cohort of PD subjects comprehensively assessed in the previous U-M Udall Center cycle will be recruited for additional longitudinal assessments with a supplemental cohort of new PD subjects. The CRC has standardized methods for data collection, entry, and verification, as developed by the Biostatistics and Data Management Core (BDMC; Core D), compliant with HIPAA and IRB regulations. Data collected is consistent with NINDS Common Data Elements to facilitate transfer of data to the NINDS Data Management Repository using ProFORMS. The CRC will closely collaborate with the Neuroimaging Resource Core (NRC; Core C) to coordinate in vivo neuroimaging assessments of subjects. The CRC will serve as the liaison between Project III and the investigators of the Dutch Parkinson and Cognition (DUPARC) study at the University of Groningen (P.I. Dr. Teus van Laar). The CRC will continue to foster existing collaborations with the Pacific Udall Center (P.I. Dr. Thomas Montine) and the University of Rochester Udall Center (P.I. Dr. Ray Dorsey). The specific goals of the CRC are: 1. To recruit, enroll, and retain PD subjects (net enrollment target of N=100 eligible PD subjects) and age- and gender-matched NC subjects (N=20) for the U-M Udall Center Projects I and III in support of their scientific goals. 2. To comprehensively assess all subjects with well-established clinical, motor function, and neuropsychological instruments at baseline and follow-up. 3. To provide the organizational structure and operations oversight for the U-M Udall Center Projects I and III and interact and coordinate with other Cores to assure prompt neuroimaging assessment (NRC) and data transfer and analysis (BDMC). 4. Facilitate and coordinate data transfer from the University of Groningen DUPARC study. 5. Support existing collaborations with other Udall Centers and facilitate transfer of data to and from these Udall Centers

核心b：摘要/抽象