# Clinical Protocol and Data Management

> **NIH NIH P30** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2020 · $179,855

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT
ABSTRACT
Clinical Protocol and Data Management (CPDM) serves a critical role at Huntsman Cancer Institute (HCI) of
overseeing the successful execution of clinical research. CPDM processes yield efficient and high-quality
outcomes to support the Cancer Center in its mission to create and improve cancer treatments, with the
ultimate goal to relieve the suffering of cancer patients. The leadership of CPDM has both administrative and
clinical expertise to sustain a culture of exceptional clinical research, with clinical trials as the most important
choice of treatment for patients at HCI.
The largest centralized group within CPDM is the Clinical Trials Office (CTO, 129 FTEs), which has a well-
defined mission to support interventional treatment trials at HCI. The primary goal of the CTO is to promote
efficient completion of compliant clinical trials, while ensuring patient safety, study integrity, and streamlined
study activation. The CTO provides robust regulatory, financial, clinical, and data coordination support to
principal investigators in the HCI community. The CTO seeks a balanced portfolio serving our patient
population and encompassing rare disease clinical trials. Currently, the CTO oversees approximately 390
active clinical trials, caring for more than 1,800 clinical trial participants.
HCI conducts Data and Safety Monitoring (DSM) for all investigator-initiated clinical trials, commensurate with
their level of risk and as defined in our National Cancer Institute-approved Data and Safety Monitoring Plan.
Trials overseen include physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and
efficacy, effectiveness, and comparative trials (Phase III).
HCI is committed to serving all residents of our catchment area, the State of Utah, including women, children,
and underserved populations. We aim to provide exceptional care and access to the latest advances in cancer
treatment through participation in clinical research. HCI maintains heightened awareness to ensure that
underrepresented minorities in our catchment area receive equitable care and opportunities for clinical trials at
our Center. Underrepresented groups in Utah fall primarily into two categories: 1) minorities based on race,
ethnicity, and low socioeconomic status, and 2) geographically disadvantaged populations consisting of Utah’s
rural/frontier residents, who have significant barriers to access to specialty care and treatment of complex
diseases, including cancer. The demographics of underserved minorities accrued to treatment trials at HCI
parallel the gender, racial, and ethnic demographics of our catchment area cancer population and the
population of new cancer patients seen at our Center.

## Key facts

- **NIH application ID:** 9935893
- **Project number:** 2P30CA042014-31
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** David K Gaffney
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $179,855
- **Award type:** 2
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9935893

## Citation

> US National Institutes of Health, RePORTER application 9935893, Clinical Protocol and Data Management (2P30CA042014-31). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9935893. Licensed CC0.

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