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：监管和人体研究操作核心 C 监管和人体研究运营 (RHSO) 核心支持精准老化网络的 (PAN) 人体实验的科学严谨性和法规遵从性的目标和目标 在项目 1、2、3 和 4 中进行。RHSO 核心监督标准操作的实施 程序（SOP）、审核以及人类研究人员在监管和质量控制方面的培训 该核心还将有助于解决样本和实时监控的潜在问题。 数据采集​​。 RHSO 核心目标和目标包括执行和管理所有人的监管流程 所需的核心和项目 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，并将制定和强制遵守 用于人类研究数据和样本收集的 SOP 还将支持和启用数据。 共享以加快研究转化，优化认知健康寿命并预防或减少 阿尔茨海默病 (AD) 和 AD 相关痴呆症 (ADRD) 的负担。 RHSO 核心由 Brinton 领导，他是国际公认的发现和转化者 神经科学家，在领导高效团队进行大规模研究方面拥有良好的记录 她建立了一个强大的团队来协助这项工作，其中包括埃尔南德斯。 具有根据既定 SOP、良好临床实践 (GCP) 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 Rodgers 在良好实验室规范 (GLP) 和良好执行规范方面拥有丰富的经验 生产规范 (GMP)。