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:
- 金额:$ 27.95万
- 依托单位:
- 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:
- 关键词:AddressAdherenceAge-associated memory impairmentAgingAlzheimer&aposs DiseaseAlzheimer&aposs disease related dementiaAmericanCognitiveConsent FormsDataData CollectionData Science CoreDevelopmentDocumentationEnsureEthicsEthnic OriginFinancial DisclosuresGoalsGood Clinical PracticeGuidelinesHealthHealth Insurance Portability and Accountability ActHumanHuman ResourcesIndependent LivingInstitutional Review BoardsInternationalLongevityMissionMonitorParticipantProceduresProcessProductivityProtocol ComplianceProtocols documentationQuality ControlRegulationReproducibilityResearchRiskSafetyServicesSiteSpecimenSystemTrainingTraining ProgramsTranslational ResearchUpdateWorkdata acquisitiondata qualitydata sharingexperienceexperimental studygood laboratory practicehealthspanhuman studyhuman subjectimprovedmaterial transfer agreementoperationpreventprogramsreal time monitoringsample collectionsexsocioeconomicssymposiumvirtual
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
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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ROBERTA EILEEN BRINTON其他文献
ROBERTA EILEEN BRINTON的其他文献
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{{ truncateString('ROBERTA EILEEN BRINTON', 18)}}的其他基金
Translational Research in Alzheimer's Disease and related Dementias (TRADD)
阿尔茨海默病和相关痴呆症的转化研究 (TRADD)
- 批准号:
10709167 - 财政年份:2023
- 资助金额:
$ 27.95万 - 项目类别:
Novel Intranasal Formulations of Allopregnanolone, a Regenerative Therapeutic for Alzheimer's Disease
Allopregnanolone 的新型鼻内制剂,一种阿尔茨海默病的再生疗法
- 批准号:
10698555 - 财政年份:2023
- 资助金额:
$ 27.95万 - 项目类别:
PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
PhytoSERM 预防更年期相关脑代谢和认知能力下降的功效:双盲、随机、安慰剂对照 2 期临床试验
- 批准号:
10560591 - 财政年份:2022
- 资助金额:
$ 27.95万 - 项目类别:
PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health
PhytoSERM 针对更年期潮热和持续大脑健康
- 批准号:
10547639 - 财政年份:2022
- 资助金额:
$ 27.95万 - 项目类别:
PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial
PhytoSERM 预防更年期相关脑代谢和认知能力下降的功效:双盲、随机、安慰剂对照 2 期临床试验
- 批准号:
10344556 - 财政年份:2022
- 资助金额:
$ 27.95万 - 项目类别:
PhytoSERM for Menopausal Hot Flashes and Sustained Brain Health
PhytoSERM 针对更年期潮热和持续大脑健康
- 批准号:
10707107 - 财政年份:2022
- 资助金额:
$ 27.95万 - 项目类别:
Regulatory and Human Study Operations (RHSO) Core C
监管和人体研究运营 (RHSO) 核心 C
- 批准号:
10689308 - 财政年份:2021
- 资助金额:
$ 27.95万 - 项目类别:
Regulatory and Human Study Operations (RHSO) Core C
监管和人体研究运营 (RHSO) 核心 C
- 批准号:
10270190 - 财政年份:2021
- 资助金额:
$ 27.95万 - 项目类别:
Undergraduate Readying for Burgeoning Research for American Indian Neuroscientists
本科生为美洲印第安人神经科学家的新兴研究做好准备
- 批准号:
10199069 - 财政年份:2019
- 资助金额:
$ 27.95万 - 项目类别:
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