Regulatory and Human Study Operations (RHSO) Core C

监管和人体研究运营 (RHSO) 核心 C

• 批准号: 10491851
• 负责人: ROBERTA EILEEN BRINTON
• 金额: $ 27.95万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491851
• 关键词: Address; Adherence; Age-associated memory impairment; Aging; Alzheimer' s Disease; Alzheimer' s disease related dementia; American; Cognitive; Consent Forms; Data; Data Collection; Data Science Core; Development; Documentation; Ensure; Ethics; Ethnic Origin; Financial Disclosures; Goals; Good Clinical Practice; Guidelines; Health; Health Insurance Portability and Accountability Act; Human; Human Resources; Independent Living; Institutional Review Boards; International; Longevity; Mission; Monitor; Participant; Procedures; Process; Productivity; Protocol Compliance; Protocols documentation; Quality Control; Regulation; Reproducibility; Research; Risk; Safety; Services; Site; Specimen; System; Training; Training Programs; Translational Research; Update; Work; data acquisition; data quality; data sharing; experience; experimental study; good laboratory practice; healthspan; human study; human subject; improved; material transfer agreement; operation; prevent; programs; real time monitoring; sample collection; sex; socioeconomics; symposium; virtual

SUMMARY/ABSTRACT: Regulatory and Human Study Operations Core C The Regulatory and Human Study Operations (RHSO) Core supports the Precision Aging Network’s (PAN) goals and objectives by ensuring scientific rigor and regulatory compliance of human experiments conducted in Projects 1, 2, 3 and 4. The RHSO Core oversees implementation of standard operating procedures (SOPs), auditing, and training of human study personnel in regulatory and quality control processes. This Core also will contribute to solving potential issues with real time monitoring of specimen and data acquisition. The RHSO Core goals and objectives include execution and management of regulatory processes for all Cores and Projects as required. The RHSO Core will work with the Data Science (DS) Core to ensure ethical, precise and reproducible human study data collection and quality, and will develop and enforce adherence to the SOPs for human study data and sample collection. The RHSO Core will also support and enable data sharing to expedite translation of research to optimize cognitive healthspan and to prevent or reduce the burden of Alzheimer’s disease (AD) and AD-related dementias (ADRD). The RHSO Core is led by Brinton who is an internationally recognized discovery and translational neuroscientist with a well-established track record of leading highly effective teams conducting large scale milestone-driven projects. She has established a strong team to assist in this effort. This includes Hernandez with experience in executing large projects in accordance to established SOP, good clinical practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations, and Rodgers who has extensive experience executing in Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).

摘要/摘要：监管和人类研究操作核心C 监管和人类研究操作（RHSO）核心支持精确的老化网络 （PAN）通过确保人类实验的科学严格和监管合规性来实现目标和目标 在项目1、2、3和4中进行。RHSO核心监督标准操作的实施 在监管和质量控制中的人类研究人员的程序（SOP），审计和培训 过程。该核心还将通过实时监视标本和 数据获取。 RHSO核心目标包括执行和管理所有人的监管流程 核心和项目根据需要。 RHSO核心将与数据科学（DS）核心合作，以确保道德， 精确且可重复的人类研究数据收集和质量，并将发展并强制遵守 人类研究数据和样本收集的SOP。 RHSO核心还将支持和启用数据 共享以加快研究的翻译，以优化认知健康范围并防止或减少 阿尔茨海默氏病（AD）和广告相关痴呆症（ADRD）的负担。 RHSO核心由布林顿（Brinton）领导，布林顿（Brinton）是国际认可的发现和翻译 神经科学家拥有良好的领先高效团队的良好往绩记录 里程碑驱动的项目。她已经建立了一支强大的团队来协助这项努力。这包括埃尔南德斯 根据既定的SOP，良好的临床实践（GCP）的执行大型项目的经验， 和国际协调会议（ICH）指南，以履行所有联邦和地方法规，以及 在良好的实验室实践（GLP）和良好的良好经验执行经验的罗杰斯（Rodgers） 制造实践（GMP）。