# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2021 · $335,912

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT
PROJECT SUMMARY/ABSTRACT
The CPDM provides unified oversight and support for coordinating, facilitating, and reporting on clinical trials
managed by the University of California Comprehensive Cancer Center. The CPDM research strategy is
composed of four sections that describe the processes involved in conducting clinical trials uniformly and
safely. Part I: Clinical Protocol and Data Management is managed by the Office of Clinical Research (OCR),
which is led by Karen Kelly, MD (OCR Medical Director) and Ahmed Bayoumi, MD (OCR Executive Director).
The OCR includes six units: operations, business, regulatory, clinical, data, and correlative lab thus providing
Cancer Center investigators with centralized services to conduct clinical trials. The OCR staff work cohesively
with the investigators to provide subjects with exceptional care such that toxicities are minimized, trial
adherence is maintained, and data quality is achieved. Part II: Data and Safety Monitoring. All clinical trials
conducted under UCDCCC include provisions for data and safety monitoring. The Data Safety and Monitoring
Plan (DSMP) focuses on patient safety, protocol adherence, and data quality. In anticipation for the CCSG
competitive renewal, the DSMP was revised and subsequently approved by the NCI in August 2020. Part III:
Inclusion of Minorities and Women in Clinical Trials. The UCDCCC is dedicated to the inclusion of women and
minorities in cancer clinical trials and complies with the NIH regulations on accrual of these populations. Entry
criteria for cancer studies are disease, not gender or ethnicity specific. However, the Center has recruitment
strategies specifically focused on women and minority populations who experience disparities, for example,
liver cancer (Asian Americans and all populations of color), prostate cancer (African Americans and
Hispanics/Latinos), and breast cancer (African Americans, Hispanics/Latinos, and Asian Americans). Part IV:
Inclusion of Across the Lifespan in Clinical Trials. To ensure patients from all ages are recruited to trials,
UCDCCC has intensified its plans to recruit pediatric patients and will begin raising awareness and developing
recruitment plans to enroll patients > 64 years old.

## Key facts

- **NIH application ID:** 10269794
- **Project number:** 2P30CA093373-19
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** KAREN L KELLY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $335,912
- **Award type:** 2
- **Project period:** 2002-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10269794

## Citation

> US National Institutes of Health, RePORTER application 10269794, Clinical Protocol and Data Management (2P30CA093373-19). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10269794. Licensed CC0.

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