# Admin Core

> **NIH NIH U10** · UNIVERSITY OF CHICAGO · 2020 · $2,928,869

## 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 Administrative Core provides the components of the SDMC critical to a) leadership within the SDMC
overall and between Core components, b) coordination with NRG Oncology Operations to effectively provide to
the group necessary support for the research agenda and for investigators, including vital functions such as
data and trial quality assurance and c) coordination with other Network groups and with the NCI to collectively
meet the goals of the NCTN.
 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. The re-organization to provide a structure that capitalizes on a wealth of skills and
experience while avoiding inefficiencies was a challenge successfully met in the first cycle. The current
leadership structure provides seamless work among sites under common procedures, with divisions organized
by function rather than geography, while continuing to take advantage of longstanding expertise that may
reside in a specific office (and thus are not redundant). Success during the first cycle is evidence by over 45
new trials either initiated or currently approved and in development, while 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. The NRG Oncology trials accruing during 2014-2017 represent 34% of all accruing NCTN trials.
Publications from the group in the first cycle number well over 300, including 39 methodology articles by SDMC
statisticians. The administrative structure of the SDMC has allowed it to serve as a highly functioning
productive resource for NRG Oncology and the NCTN.
 In the second cycle of the NCTN, the Administrative Core will continue to enhance the integration of the
group towards a seamless unit that serves all the operational needs of the SDMC as it carries out its mission.
Specifically, the Administrative Core will provide the governance, strategic planning, scientific direction,
logistical oversight, administrative resources and decision-making for the NRG Oncology Statistics and Data
Management Center. The Core will lead critical liaisons with the NRG Operations Center, NCTN member
groups, the NCI, pharmaceutical companies, and the FDA to ensure that research goals are met. The Core will
provide quality assurance oversight to the other SDMC sections and to the NRG investigative sites, ensuring
the integrity of the database and trial findings. Finally, the core will provide administrative resources and
training to SDMC staff through adherence to its library of St...

## Key facts

- **NIH application ID:** 9901458
- **Project number:** 5U10CA180822-07
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** James J. Dignam
- **Activity code:** U10 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,928,869
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9901458

## Citation

> US National Institutes of Health, RePORTER application 9901458, Admin Core (5U10CA180822-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9901458. Licensed CC0.

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