# Data Management and Reporting Group

> **NIH NIH UM2** · RHO FEDERAL SYSTEMS DIVISION, INC. · 2021 · $1,269,065

## Abstract

PROJECT SUMMARY/ABSTRACT—DATA MANAGEMENT AND REPORTING GROUP 
 High-quality clinical data management has been a cornerstone of Rho services since its inception. Over 
the last 2 decades, Rho has served as the coordinating center for numerous NIH-sponsored observational 
studies and clinical trials, which has given us extensive experience developing, implementing, and maintaining 
innovative and reliable data systems for clinical research. In anticipation of the consolidation of study 
coordination activities across DAIT consortia, Rho has worked over the last year to standardize methods and 
processes across our current consortia. 
 The Data Management and Reporting Group Component will provide—across the 3 disease groups— 
high-quality, integrated, and secure information management systems and well-developed procedures for the 
collection of clinical and mechanistic data, the randomization of study subjects, the tracking of specimen 
collection and distribution, and the reporting of safety data. New DAIT studies coordinated by the Center will 
use the following systems for data management and reporting: 
 • Medidata Rave (an industry-leading, state-of-the-art, web-based data management tool) for the 
 receipt, entry, verification, processing, correcting, storage, tracking, transmission and reporting on all 
 clinical data and clinical laboratory data. Medidata Rave minimizes routine data entry errors and 
 boosts efficiency through robust data validation functionality that effectively turns data capture and 
 data cleaning into 1 process. 
 • RhoRAND™ for 24-7 access to participant registration and randomization using web-based or 
 interactive voice response technology. Non-computerized methods will be available if needed. 
 • Oracle Argus safety data system for entering, tracking, coding, reporting, analyzing, and archiving SAE 
 data for clinical studies in accordance with federal and international regulations. 
 Rho will carefully and comprehensively monitor accruing study data for enrollment status, visit and 
procedure completion status, and safety triggers. RhoPortal will be used across the DAIT Consortia to provide 
near real-time access to information about study progress. Any data quality or study progress metric that the 
Consortia Investigators or DAIT personnel wish to see routinely can be made available via RhoPortal. 
 We will use the CDISC CDASH standard for clinical data management for new studies managed by the 
Center. CDASH provides a study with a library of data elements that are also an industry standard and is an 
excellent starting point for efficiently setting up a clinical data management system. Rho has already begun the 
process of developing standards for forms and variables that do not exist in CDASH, but which are common 
across our studies and therapeutic areas. This “RhoDASH” global library will grow organically over time, and 
will allow us to store final study data in a standard format that can be uploaded to d...

## Key facts

- **NIH application ID:** 10150746
- **Project number:** 5UM2AI117870-07
- **Recipient organization:** RHO FEDERAL SYSTEMS DIVISION, INC.
- **Principal Investigator:** Jeff Abolafia
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,269,065
- **Award type:** 5
- **Project period:** 2020-05-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10150746

## Citation

> US National Institutes of Health, RePORTER application 10150746, Data Management and Reporting Group (5UM2AI117870-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10150746. Licensed CC0.

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