Core B: Clinical Resource Core

核心 B：临床资源核心

基本信息

批准号：
10672408
负责人：
Nicolaas Ida Bohnen
金额：
$ 25.4万
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/10672408
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 cohort data exchange 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：总结/摘要临床资源核心（CRC；核心 B）将为人类受试者项目 I 和 III 提供支持密歇根大学 (U-M) 尤德尔中心通过招募、注册和详细的临床评估帕金森病 (PD) 受试者和年龄和性别匹配的对照 (NC) 受试者。该产品的一个独特之处在于拟议的 U-M Udall 中心的优势在于它将利用独特的深度临床和神经影像表型 PD 来自我们之前的尤德尔中心 (09/2014-08/2020) 的人口。 PD受试者队列全面在之前的密歇根大学尤德尔中心周期中进行评估的人将被招募进行额外的纵向评估新PD受试者的补充队列。 CRC 拥有标准化的数据收集、输入和处理方法验证，由生物统计和数据管理核心（BDMC；核心 D）开发，符合 HIPAA 和 IRB 法规。收集的数据与 NINDS 通用数据元素一致，以方便传输使用 ProFORMS 将数据传输到 NINDS 数据管理存储库。 CRC将与神经影像资源核心（NRC；核心 C）协调受试者的体内神经影像评估。 CRC 将充当项目 III 和荷兰帕金森病研究中心的调查人员之间的联络人格罗宁根大学的认知 (DUPARC) 研究（P.I. Teus van Laar 博士）。 CRC将继续促进与太平洋尤德尔中心（P.I. Dr. Thomas Montine）和大学的现有合作罗彻斯特尤德尔中心（P.I. Ray Dorsey 博士）。 CRC 的具体目标是： 1.招募、注册和保留PD受试者（净注册目标N = 100名合格的PD受试者）和年龄和年龄密歇根大学尤德尔中心项目 I 和 III 的性别匹配 NC 受试者 (N=20)，以支持其科学目标。 2. 全面评估所有具有良好临床、运动功能和功能的受试者基线和随访时的神经心理学工具。 3. 为密歇根大学尤德尔中心项目 I 和 III 提供组织结构和运营监督并与其他核心互动和协调，以确保及时的神经影像评估 (NRC) 和数据传输和分析（BDMC）。 4. 促进和协调格罗宁根大学 DUPARC 研究的数据传输。 5. 支持与其他 Udall 中心的现有合作，并促进这些 Udall 中心之间的数据传输中心