# Pharmaceutical Research Center Shared Resource

> **NIH NIH P30** · UNIVERSITY OF WISCONSIN-MADISON · 2021 · $90,583

## Abstract

PROJECT SUMMARY/ABSTRACT 
The Pharmaceutical Research Center (PRC) operates within the University of Wisconsin Health System (UW 
Health) and is responsible for the safe and ethical provision of investigational study medications to research 
subjects enrolled in all clinical drug trials within our hospitals and clinics, including those of The University of 
Wisconsin Carbone Cancer Center (UWCCC). The mission of the PRC is to ensure that drug research 
protocols proceed optimally through established medication use systems and in accordance with all federal, 
state, institutional, and sponsor regulations governing clinical research. PRC services enhance regulatory rigor 
and subject safety while facilitating the conduct of clinical drug research within our academic medical center. 
For each clinical drug trial, PRC establishes study drug handling, distribution, preparation, and destruction 
procedures; develops a protocol specific workflow; creates an investigational drug monograph(s) for health 
care providers; educates health care staff regarding protocol procedures; creates the physician orders set; 
manages drug inventory and accountability; prepares drugs and/or monitors drug preparation; monitors drug 
expiration and retest dates; provides quality assurance audits; and reviews all protocol amendments. In 
addition, PRC provides services that are specifically tailored to the unique needs of UWCCC investigators. For 
example, PRC manages trials involving gene therapy and hazardous oncology drugs; provides accurate 
response to drug interaction inquiries from investigators and care providers; and verifies authorized prescriber 
status in accordance with NCI requirements. During the current CCSG funding cycle, PRC has enabled 
UWCCC investigators to implement 170 peer-reviewed clinical drug trials and has provided study drug 
oversight for an average of 200 cancer focused clinical trials each year. PRC strives to refine, enhance and/or 
expand our services to meet the evolving needs of the UWCCC research faculty and our research subjects, 
while operating in rapidly changing healthcare and regulatory environments. Our specific aims are to: 1) 
provide detailed protocol review and feasibility assessment of each UWCCC protocol; 2) ensure all UWCCC 
study protocols comply with Good Clinical Practice (GCP) standards; 3) provide services essential to the 
advancement of clinical cancer research; and 4) facilitate clinical drug research within UW Health satellite 
pharmacies that extend clinical cancer research across our catchment area. Base funding from the CCSG 
allows PRC leaders to serve as members of the UWCCC scientific leadership team to ensure PRC is well 
positioned to meet the evolving needs of UWCCC investigators and thereby enhance the ability of our 
members to enroll patients onto investigator initiated clinical studies that ultimately will improve outcomes for 
our patients and society.

## Key facts

- **NIH application ID:** 10147663
- **Project number:** 5P30CA014520-47
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** HOWARD H BAILEY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $90,583
- **Award type:** 5
- **Project period:** 1997-04-25 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10147663

## Citation

> US National Institutes of Health, RePORTER application 10147663, Pharmaceutical Research Center Shared Resource (5P30CA014520-47). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10147663. Licensed CC0.

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