Regulatory and Human Study Operations (RHSO) Core C

NIH RePORTER · NIH · U19 · $287,146 · view on reporter.nih.gov ↗

Abstract

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).

Key facts

NIH application ID
10270190
Project number
1U19AG065169-01A1
Recipient
UNIVERSITY OF ARIZONA
Principal Investigator
ROBERTA EILEEN BRINTON
Activity code
U19
Funding institute
NIH
Fiscal year
2021
Award amount
$287,146
Award type
1
Project period
2021-09-30 → 2026-08-31