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：法规和人类研究操作核心C 监管和人类研究操作(RHSO)核心支持精确老化网络的 (PAN)通过确保人体实验的科学严谨性和合规性来实现目标和目的 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)、审核和人体研究人员在监管和质量控制方面的培训 流程。该核心还将有助于解决潜在问题，实时监测标本和 数据采集。 RHSO的核心目标和目标包括执行和管理所有 根据需要提供核心和项目。RHSO核心将与数据科学(DS)核心合作，以确保 精确和可重复的人体研究数据收集和质量，并将制定和强制遵守 人体研究数据和样本收集的标准操作规程。RHSO核心还将支持和启用数据 共享以加快研究成果的翻译，以优化认知健康范围并预防或减少 阿尔茨海默病(AD)和AD相关痴呆(ADRD)的负担。 RHSO核心由布林顿领导，他是国际公认的发现和翻译 神经学家，具有领导高效团队进行大规模工作的良好记录 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一努力。这包括赫尔南德斯 具有按照既定的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，以满足所有联邦和地方法规，以及 罗杰斯，在良好的实验室操作规范(GLP)和良好的 生产实践(GMP)。