# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $1,064,552

## Abstract

Clinical Protocol and Data Management: Summary/Abstract
The goal of HDFCCC Clinical Protocol and Data Management (CPDM) is to support and facilitate clinical trial
conduct in the HDFCCC across the entire life cycle of a clinical trial, including protocol development, activation,
accrual and conduct, monitoring, closure, and reporting. Clinical protocol development and data management
functions in the HDFCCC are provided by the Clinical Research Support Office (CRSO), which provides the
infrastructure to support the efficient development, implementation, conduct, and reporting of clinical research
studies, including the management of clinical research personnel across the HDFCCC. The CRSO also
integrates and coordinates clinical cancer research activities with campus-wide entities affecting clinical trial
conduct, such as the UCSF IRB and the campus-wide UCSF Office of Research. Data and safety monitoring
(DSM) functions, as detailed in the NCI-approved Data and Safety Monitoring Plan (DSMP) of the HDFCCC,
are carried out by the DSM staff and overseen by the Data and Safety Monitoring Committee (DSMC). In
addition to conducting data and safety review, DSM activities include the development, maintenance, and
management of clinical research training for investigators and clinical research training for clinical research
personnel, undertaken in collaboration with the CRSO. CPDM also facilitates the HDFCCC’s commitment to
accrue diverse populations of patients on clinical studies, including women, minorities, and individuals across
the lifespan. The HDFCCC strives to ensure that the diverse population of its catchment area has equitable
access to, representation in, and benefit of clinical research. HDFCCC analyzes demographic data relating to
race/ethnicity, gender, and age, to identify areas to improve inclusion of minorities, women, and individuals
across the lifespan in clinical research. Specifically, the CPDM (1) aggregates data regarding catchment area,
HDFCCC, and clinical trial enrollment demographics, at a disease-specific level; (2) analyzes these data to
understand potential reasons for disparities that are encountered; (3) based on these data, works with
investigators, site committees, and Community Outreach and Engagement (COE) to develop focused action
plans; and (4) defines and analyzes metrics of success to evaluate progress in addressing these disparities.

## Key facts

- **NIH application ID:** 10712683
- **Project number:** 2P30CA082103-24
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Charalambos Andreadis
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,064,552
- **Award type:** 2
- **Project period:** 1999-08-05 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10712683

## Citation

> US National Institutes of Health, RePORTER application 10712683, Clinical Protocol and Data Management (2P30CA082103-24). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10712683. Licensed CC0.

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