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Regulatory and Human Study Operations (RHSO) Core C

监管和人体研究运营 (RHSO) 核心 C

基本信息

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
项目类别：
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&apos s Disease Alzheimer&apos 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

项目摘要

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：法规和人体研究操作核心C