# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF WISCONSIN-MADISON · 2021 · $308,101

## Abstract

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT
The Clinical Research Central Office (CRCO) provides the centralized infrastructure for clinical research
activities at the UW Carbone Cancer Center (UWCCC). The CRCO includes 87 FTEs who support 244 faculty
PIs with an annual operating budget of $6.4M; annual CCSG provides $248K (directs) of the total CRCO budget.
Under the leadership of Center Director Dr. Howard Bailey and Associate Director for Clinical Research, Dr.
Ruth O’Regan (DT), UWCCC has significantly expanded and centralized the CRCO infrastructure, supported
by a $2M investment (non-CCSG) by Dr. Bailey in new annual operating funds. Restructuring has yielded
expertise and efficiencies in central administration, study coordination, patient care, regulatory, fiscal,
informatics, quality assurance, billing compliance, and educational teams. In 2016, the CRCO supported accrual
of 2,582 subjects to 257 research studies across the center. Of the 165 treatment intervention clinical trials in
2016, the sponsor breakdown was as follows: Externally peer reviewed (14 studies, or 8%), Industrial (54, or
33%), Institutional (23, or 14%), and National (74, or 45%). Promising early results of centralization include the
reversal in 2016 of a 7-year decline in treatment intervention accrual, improvement in study activation metrics,
and reduced CRCO staff turnover. The CRCO supports clinical research conducted on site, through NCTN and
ETCTN, through our statewide IIT network Wisconsin Oncology Network (WON), and through our memberships
in the Big Ten Cancer Research Consortium (BTCRC) and National Comprehensive Cancer Network (NCCN),
with whom we are collaborating and developing new IITs. Research Informatics has expanded, led by a newly
hired Assistant Director, Business Analyst, CTMS manager, and a revised OnCore® Support Team, increasing
our eCRF development 7-fold. The QA/Compliance team executes our DSMP, enacting risk-based monitoring,
determined by study sponsorship and PRMC-adjudicated risk level. Monitoring, auditing, and data quality and
assurance reviews include Internal Audits, Compliance Reviews, and Review of SAE reporting. The CRCO has
initiated multiple new initiatives to improve our accrual of women and minorities to clinical trials, including wider
interactions with the UWCCC Cancer Health Disparities Initiative, increasing support of translator and multi-
lingual consenting services, and targeted, multi-culturally appropriate media outreach efforts. The CRCO
envisions continued expansion via vigorous support from the UWCCC and industry partnerships, enabling an
increasing percentage of our patients’ access to innovative and impactful clinical trials.

## Key facts

- **NIH application ID:** 10147680
- **Project number:** 5P30CA014520-47
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** ANNE M TRAYNOR
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $308,101
- **Award type:** 5
- **Project period:** 1997-04-25 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10147680

## Citation

> US National Institutes of Health, RePORTER application 10147680, Clinical Protocol and Data Management (5P30CA014520-47). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10147680. Licensed CC0.

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