# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF HAWAII AT MANOA · 2024 · $257,186

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT - ABSTRACT
 The Clinical Protocol and Data Management (CPDM) function at the University of Hawaiʻi Cancer Center
(UHCC) is situated within the Clinical Trials Office (CTO). CPDM supplies the infrastructure and access to
state-of-the-art clinical trials for Hawaiʻi’s community-based providers and their patients. Led by Medical
Director Jonathan K. Cho, MD, IIT & Regulatory Director Toshiaki Iwase MD, PhD, and Administrative Director
Anna Quinn, MPH, the CPDM oversees central management functions for coordinating, facilitating, and
reporting on cancer clinical for our Center. These trials encompass national group, externally peer-reviewed,
industry-sponsored, and investigator-initiated trials (IITs). Other vital components of CPDM include regulatory
affairs, protocol administration and management, protocol information technology management via OnCore our
Clinical Trials Management System, staff training, and investigator education and training activities. Disease
Site Working Groups (DSWGs) function to curate research portfolios supported by CPDM that cater to our
catchment area's needs, and our Patient Advocacy Council focuses on educating the community about clinical
trials, facilitating community and patient engagement, and promoting enrollment in cancer trials.
 Data and Safety Monitoring (DSM) is complementary to CPDM. It provides the framework for the review
of data and safety monitoring plans for all protocols and ensures ongoing monitoring of patient safety and data
quality. The UHCC Compliance Office steers the quality assurance and audit functions of DSM. This office
serves as the responsible entity for quality assurance for all clinical research activities across the entire UHCC-
supported network, conducting internal audits and overseeing reports of external audits from NCORP
Research Bases (National Groups) and industry sponsors.
 Lastly, UHCC heavily emphasizes the inclusion of women, minorities, and children in clinical trials and
includes participants across the lifespan in clinical research, mainly focusing on populations with significant
cancer health disparities in Hawaiʻi and the Pacific, such as Native Hawaiians and Pacific Islanders. Almost
80% of all accruals to interventional therapeutic trials are represented by non-white minority groups, including
23% Native Hawaiian. Other interventional non-therapeutic trials, including prevention and screening studies,
are specifically targeted toward Native Hawaiian and other Pacific Islander populations and have an even
higher rate of minority enrollment. UHCC has successfully enrolled pediatric cancer patients in its clinical trials.
While less than 1% of Hawai‘i’s cancer patients are under 20 years old, 4.2% of all interventional clinical trial
enrollees at UHCC were children in 2022.

## Key facts

- **NIH application ID:** 10935919
- **Project number:** 2P30CA071789-23
- **Recipient organization:** UNIVERSITY OF HAWAII AT MANOA
- **Principal Investigator:** Jonathan Karl Cho
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $257,186
- **Award type:** 2
- **Project period:** 1997-07-01 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10935919

## Citation

> US National Institutes of Health, RePORTER application 10935919, Clinical Protocol and Data Management (2P30CA071789-23). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10935919. Licensed CC0.

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