# Core B: Clinical Core

> **NIH NIH P01** · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · 2024 · $325,335

## Abstract

Clinical Core Abstract
The Clinical Core will: provide the logistical support for Projects 1 and 2, initiate the 5 clinical
sites, monitor recruitment of subjects across the study sites into the remission and active lupus
cohorts (SLE-R and SLE-A) and healthy controls (HC), and ensure that subjects are correctly
classified and meet criteria for their respective cohorts. The Clinical Core will also ensure that
the subset of subjects enrolled in Project 2 meet all additional enrollment criteria for this project.
With the assistance of the Biostatistics and Data Integration Core, the Clinical Core will monitor
the distribution of race and ethnicity in SLE-R to optimize demographic comparability between
SLE-R and SLE-A and HCs. It will track the progress of SLE-R subjects with site notifications of
upcoming visits for Project 1 and 2 assessments and facilitate and coordinate biospecimen
shipments to the Feinstein Institutes of Medical Research. Additionally, the Clinical Core will
monitor protocol compliance, data integrity, and regulatory compliance. Although safety issues
are likely to be few if any in this observational study, the Clinical Core will implement and
maintain the Data Safety Monitoring Plan.

## Key facts

- **NIH application ID:** 10763688
- **Project number:** 1P01AI172523-01A1
- **Recipient organization:** FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
- **Principal Investigator:** Cynthia Aranow
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $325,335
- **Award type:** 1
- **Project period:** 2024-05-09 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10763688

## Citation

> US National Institutes of Health, RePORTER application 10763688, Core B: Clinical Core (1P01AI172523-01A1). Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/grant/nih/10763688. Licensed CC0.

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