# Data Management Core

> **NIH NIH U10** · UNIVERSITY OF CHICAGO · 2020 · $4,320,496

## Abstract

The mission of the NRG Oncology Statistics and Data Management Center (SDMC) is to provide all
necessary expertise and personnel for the design, conduct and analysis of clinical trials and associated
research for NRG Oncology, a member group of the NCI National Clinical Trials Network (NCTN) program.
The Data Management Core of the SDMC provides the expertise to develop software, data collection
mechanisms, database storage, and data management processes for state of the art clinical conduct, and to
implement these tools and methods to manage the NRG Oncology clinical trial portfolio.
 The 2019-2024 cycle represents the second period of the NCTN program, which succeeded the NCI
Cancer Cooperative Group program, of which NRG Oncology was formed by the unification of three existing
Cooperative Groups. During the first cycle of the NCTN, the NRG Oncology SDMC has expended significant
effort harmonizing data management and information technology practices in order to successfully transform
into a united entity operating under common procedures and using the Medidata Rave® database system.
While maintaining a geographically distributed model, the Data Management Core now operates as a single
highly efficient and productive unit, as evidenced by the successful initiation of 32 new trials and final approval
on an additional 14 trials now in development, while continuing to maintain accrual and/or follow-up to primary
and secondary endpoint reporting on over 80 additional trials that were active at the inception of NRG
Oncology. Publications from the group in the first cycle number well over 300.
 In this second NCTN cycle, the Data Management Core will build on early success and continue to deliver
comprehensive support for NRG Oncology clinical trials and related research, as well as support the additional
information technology needs of the NRG Operations Center. Specifically, the Core will coordinate all study
design and process decisions in collaboration with personnel from Data Management, Quality Assurance,
Statistics, Information Technology, Protocol Development, and Imaging Technology. The Core will continue to
advance the use of Rave® functionality, including edit checks, query management, study calendar
implementation, automated email alerts, import of imaging data, and reporting functions. The Core will conduct
systems analysis of protocol data collection, review, and reporting requirements, extending Rave® intrinsic
functionality through custom programming, and develop additional data management tools for the web
environment. The Core will provide comprehensive data quality control to assure data timeliness, accuracy,
and validity. Finally, in information technology, the Core will continue to provide systems analysis, project
management, and software development to support data management, statistical, and reporting needs for both
the SDMC and the NRG Oncology Operations Office, and participate in NCTN working groups to support
NCTN initiati...

## Key facts

- **NIH application ID:** 9901461
- **Project number:** 5U10CA180822-07
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** Wendy Bergantz
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,320,496
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9901461

## Citation

> US National Institutes of Health, RePORTER application 9901461, Data Management Core (5U10CA180822-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9901461. Licensed CC0.

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