# RhoFED CDSMC

> **NIH NIH U01** · RHO FEDERAL SYSTEMS DIVISION, INC. · 2024 · $444,465

## Abstract

PROJECT SUMMARY/ABSTRACT
Standardization of data collection for analogous data collected across studies is a valuable way to streamline
study design, prevent errors in CRF and EDC development, harmonize and simplify the training of clinical
personnel, and facilitate drawing insight across studies for both hypothesis-based and hypothesis-free (e.g.,
machine learning and artificial intelligence) analysis. The NIH Common Data Elements (CDE) initiative has
sought to foster and advance this approach. Congress encouraged continued progress on CDE development
and provided guidance recommending NIH develop CDEs for “complex diseases with heterogeneous
presentations, such as autoimmune diseases” in the U.S. Senate Committee on Appropriations Explanatory
Statement for Departments of Labor, Health and Human Services, and Education, and Related Agencies
Appropriations Bill, 2023 – Summary of Budget Estimates and Committee Recommendations.
The National Institute of Allergy and Infectious Diseases (NIAID) Autoimmune Diseases Statistical and Clinical
Coordinating Center (AD-SCCC) and Clinical Data and Safety Management Center (CDSMC) provide ongoing
support for a Division of Allergy, Immunology, and Transplantation (DAIT)-sponsored program to study
autoimmune diseases. Although study endpoints are generally disease-specific and must be both clinically
relevant and ascertainable to that population, there are some common uses of background and concomitant
medications for autoimmune disease where creation of CDEs would benefit study sponsors. Development of
new CDEs and case report forms for concomitant immunosuppressive medications would facilitate the efficient
capture of treatment information and would improve quality in reporting participant disposition and in the
analysis of efficacy for investigational products. This supplement will support the CDSMC in developing and
evaluating a Concomitant Immunosuppressive Medications CDE (CIMC) to capture glucocorticoid use in
autoimmune disease in study datasets.
An interdisciplinary team will review historic approaches to recording immunosuppressive medication use and
then develop a candidate CIMC and test it in a simulation environment. With support from the Cancer Data
Standards Registry and Repository (caDSR), the project team will ensure that any existing, relevant CDEs
registered by other ICs are identified and reused, and the semantics aligned with CDEs from other NIH
projects. NCI will also provide support for producing the finalized CDEs in the NIH CDE Governance Template
for submission to the NIH for endorsement and subsequent loading into the NIH CDE Repository.

## Key facts

- **NIH application ID:** 11126447
- **Project number:** 3U01AI178773-02S2
- **Recipient organization:** RHO FEDERAL SYSTEMS DIVISION, INC.
- **Principal Investigator:** Peter N. Schmidt
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $444,465
- **Award type:** 3
- **Project period:** 2023-05-08 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11126447

## Citation

> US National Institutes of Health, RePORTER application 11126447, RhoFED CDSMC (3U01AI178773-02S2). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/11126447. Licensed CC0.

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