# Clinical Site Monitoring Group

> **NIH NIH UM2** · RHO FEDERAL SYSTEMS DIVISION, INC. · 2020 · $3,334,298

## Abstract

PROJECT SUMMARY/ABSTRACT—CLINICAL SITE MONITORING GROUP 
 The Clinical Site Management Group (CSMG) will provide clinical site monitoring support for the consortia 
included in the Allergy and Asthma Disease Group (AADG), Autoimmune Disease Group (ADG), and 
Transplantation Group (TG) except for the Immune Tolerance Network (ITN), which is handled by a different 
contract. Rho currently provides a robust on-site and centralized site monitoring strategy for all of these 
consortia, except for Consortium of Food Allergy Research (CoFAR) and will maintain our high quality of 
monitoring activities for these consortia and CoFAR as part of this cooperative agreement. The goal of the 
CSMG is to achieve effective monitoring and site management for all clinical trials conducted by the consortia 
included in the AADG, ADG, and TG. Rho proposes to achieve this goal through a combination of on-site 
visits, interim monitoring calls, remote/centralized data review, and in-house management conducted by 
clinical research associates (CRAs), study managers and/or other DAIT statistical and clinical coordinating 
center (Center) staff. Due to the specific requirements of different disease areas and their population/study and 
research focus needs, each disease group will create a clinical monitoring plan which will provide guidelines for 
site monitoring visits and centralized monitoring strategies, as well as plans for training, activation, and 
management of sites participating in the Center's trials. In addition, for each protocol, the Center will create a 
study-specific addendum to the network plan, which provides trial-specific work instructions, and references to 
trial-specific procedures, forms, documents, materials and guidelines. The primary purpose of these monitoring 
plans will be to serve as a resource for and provide standardized structure to CRAs, study managers and other 
Center staff. Centralized monitoring practices will be in place for each trial in order to supplement periodic on- 
site visits or phone contact. This allows issues or trends (both site and protocol specific) to be proactively 
identified. Following each on-site visit or call, the CRA will document the visit in a written trip report. The report 
describes the activities completed by CRA and site personnel, any issues identified during the visit/call and 
actions taken to correct deficiencies. Routine, non-serious issues will generally be resolved by the CRA or 
other Center team members in collaboration with the site staff. If site performance or regulatory compliance 
issues of significant concern are identified through on-site activities, centralized monitoring activities, or by a 
DAIT team member, a for-cause visit and/or audit may be recommended and completed by Rho staff. If it is 
determined that a for-cause visit is not needed, Rho staff and DAIT-NIAID Project Management may work with 
the site through phone calls, additional trainings, and email to resolve the issues...

## Key facts

- **NIH application ID:** 9927577
- **Project number:** 5UM2AI117870-06
- **Recipient organization:** RHO FEDERAL SYSTEMS DIVISION, INC.
- **Principal Investigator:** Emily V Birch
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $3,334,298
- **Award type:** 5
- **Project period:** 2020-05-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9927577

## Citation

> US National Institutes of Health, RePORTER application 9927577, Clinical Site Monitoring Group (5UM2AI117870-06). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9927577. Licensed CC0.

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