Core B: Clinical Core

NIH RePORTER · NIH · P01 · $325,335 · view on reporter.nih.gov ↗

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
FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
Principal Investigator
Cynthia Aranow
Activity code
P01
Funding institute
NIH
Fiscal year
2024
Award amount
$325,335
Award type
1
Project period
2024-05-09 → 2029-04-30