# Safety Oversight and Reporting Group

> **NIH NIH UM2** · RHO FEDERAL SYSTEMS DIVISION, INC. · 2021 · $287,676

## Abstract

PROJECT SUMMARY/ABSTRACT—SAFETY OVERSIGHT AND REPORTING GROUP 
 The Safety Oversight and Reporting Group (SORG) will provide safety oversight for the consortia included 
in the Allergy and Asthma Disease Group (AADG), Autoimmune Disease Group (ADG), and Transplantation 
Group (TG). Rho currently provides safety monitoring and oversight for all of these consortia, except for 
Consortium of Food Allergy Research (CoFAR) and will maintain our high quality of safety reporting activities 
for these consortia and CoFAR as part of this cooperative agreement. The goal of the SORG is to achieve a 
high-quality, standardized process for receiving, processing, following, and reporting safety information for all 
clinical trials conducted by the consortia. Rho proposes to achieve this goal by creating a comprehensive 
safety management plan that will provide structure and detailed procedures for safety oversight activities 
across all studies. In addition, for each protocol, a protocol-specific safety management plan will be created to 
outline protocol-specific requirements. The safety management plan includes description of responsibilities, 
how adverse events (AEs) and serious adverse events (SAEs) will be monitored, real-time notifications to DAIT 
and other appropriate individuals of SAEs, safety reporting workflow and timeframes for when regulatory 
reports will be provided for submission to maintain compliance for U.S. and non-U.S regulations and 
requirements, protocol-specific templates, and identification of the reference safety document for determining 
regulatory expectedness/listedness. 
 Additionally, the SORG will provide input during the development of study documents such as the 
protocol, investigator brochure, data forms, plans, and reports to ensure AEs and SAEs are monitored 
appropriately. For each protocol a lead product safety monitor (PSM) will be assigned. PSMs are assigned to a 
specific disease group, but everyone is cross-trained to provide back-up support. The PSM will educate site 
staff in how to appropriately recognize, record, and report AEs and SAEs. SAE data provided by the sites will 
be entered by the SORG into a secure, validated database specifically for entering, tracking, coding, reporting, 
analyzing and archiving SAE data. 
 The SORG will also provide support to DAIT safety oversight structures by creating thorough, high-quality 
safety reports and presentations and by maintaining the DSMB Portal, a centralized place for all materials, 
agendas, and conflict of interest information.

## Key facts

- **NIH application ID:** 10150747
- **Project number:** 5UM2AI117870-07
- **Recipient organization:** RHO FEDERAL SYSTEMS DIVISION, INC.
- **Principal Investigator:** Victoria Williams
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $287,676
- **Award type:** 5
- **Project period:** 2015-05-07 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10150747

## Citation

> US National Institutes of Health, RePORTER application 10150747, Safety Oversight and Reporting Group (5UM2AI117870-07). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10150747. Licensed CC0.

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