RhoFED CDSMC

NIH RePORTER · NIH · U01 · $256,112 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY/ABSTRACT Type 1 diabetes (T1D) is a debilitating autoimmune disease in which the body attacks and destroys the pancreas’s ability to make insulin. It can cause long term damage to or even failure of various other organs, leading to irreparable injuries such as blindness, amputation, and stroke. The NIAID Clinical Data and Safety Management Center (CDSMC) currently provides support for 2 T1D studies. This support includes safety monitoring and reporting, data management, and randomization support, all of which are key components to designing and conducting studies that answer research questions important to NIAID. Rho Product Safety takes the lead on reporting serious adverse events occurring in participants enrolled in these studies, both to NIAID and appropriate health authorities, to help ensure the safety of participants. Data management creates and maintains data collection systems that support data entry and cleaning study clinical research data. Randomization support is provided using fully validated, 21CFR11-compliant self-service web-based study configuration interface that supports a variety of randomization schema.

Key facts

NIH application ID
11110962
Project number
3U01AI178773-02S1
Recipient
RHO FEDERAL SYSTEMS DIVISION, INC.
Principal Investigator
Peter N. Schmidt
Activity code
U01
Funding institute
NIH
Fiscal year
2024
Award amount
$256,112
Award type
3
Project period
2023-05-08 → 2025-04-30