# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF HAWAII AT MANOA · 2020 · $216,284

## Abstract

ABSTRACT
 The primary purpose of Clinical Protocol and Data Management (CPDM) is to facilitate, support and
assure the generation and conduct of high impact patient research in the most efficient and safe way possible
to substantially reduce the burden of cancer for the people of Hawaii. CPDM provides the infrastructure to give
Hawaii’s community-based providers and the patients they serve access to state-of-the-science clinical trials.
 Clinical protocol and data management provides central management and oversight functions for
coordinating, facilitating, and reporting on the cancer clinical trials. These include trials from the NCI Research
Base and Cooperative Groups, industry-sponsored trials and investigator-initiated trials (IITs). It has a
complementary function to the Protocol Review and Monitoring System. The principal components of Clinical
Protocol and Data Management are the Clinical Trials Office (CTO), including regulatory affairs and protocol IT
management through OnCore, staff training activities, and investigator education and training activities.
 Data and Safety Monitoring (DSM) functions includes the DSMC (Data Safety and Monitoring Committee)
which is responsible for review of data and safety monitoring plans for all protocols, review and monitoring of
all aspects of trials related to patient safety and adverse events and oversight of IIT conduct. A second
component of DSM is Quality Assurance and Audit functions, directed by the UHCC Office of Compliance that
serves as the responsible entity for quality assurance for all clinical research activities across the entire UHCC-
supported network. This office conducts internal audits and monitors reports of external audits from NCI
Research Base and Cooperative Groups and industry sponsors.
 Inclusion of women, minorities and children onto clinical trials is a major emphasis for UHCC with a
particular focus on populations with significant cancer health disparities such as Native Hawaiians. Nearly
80% of all accrual to therapeutic trials is represented by non-white minority groups, including 17% Native
Hawaiian. Other (non-therapeutic) interventional trials include prevention and screening studies specifically
targeted toward Native Hawaiian and other Pacific Islander populations and have an even higher rate of
minority enrollment. Pediatric cancer enrollment includes 42% Native Hawaiian and 18% Filipino, both groups
that have significant disparities related to cancer mortality rates among the diverse racial and ethnic milieu in
Hawai‘i.

## Key facts

- **NIH application ID:** 9968063
- **Project number:** 5P30CA071789-20
- **Recipient organization:** UNIVERSITY OF HAWAII AT MANOA
- **Principal Investigator:** Charles J Rosser
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $216,284
- **Award type:** 5
- **Project period:** — → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9968063

## Citation

> US National Institutes of Health, RePORTER application 9968063, Clinical Protocol and Data Management (5P30CA071789-20). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9968063. Licensed CC0.

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