Regulatory and Human Study Operations (RHSO) Core C

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).

Grant Number: 5U19AG065169-05
NIH Institute/Center: NIH
Principal Investigator: ROBERTA BRINTON