# Clinical Protocoal and Data Management

> **NIH NIH P30** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $851,107

## Abstract

ABSTRACT: CLINICAL PROTOCOL AND DATA MANAGEMENT
The Clinical Protocol and Data Management (CPDM) component includes the Clinical Protocol Office (CPO)
and the compliance committees (Compliance, Data and Safety Monitoring). These groups provide centralized
management and oversight for cancer clinical trials conducted by UNC Lineberger Comprehensive Cancer
Center (LCCC) members. The CPDM delivers a full range of management and quality control services for
investigator-initiated local and multi-center trials (IITs), industry or other sponsored trials, as well as those
originating in the NCI such as the National Clinical Trials Network groups. CPDM centralizes the protocol
registration, regulatory affairs, compliance committee work, and management of clinical trials, facilitates
efficient and effective training for research personnel and monitors timely activation of protocols in support of
LCCC investigators from all relevant disciplines. IIT development is facilitated by our Clinical Development
Team made up of dedicated specialists. Carrie Lee, MD, MPH serves as Medical Director of the CPO, Claire
Dees, MD, ScM, is the Faculty Director of the Clinical Development Team, and Matt Milowsky, MD, chairs the
Clinical Trials Executive Committee composed of the disease-specific Protocol Office Disease (POD) faculty
and other leaders. In 2019, interventional trials accrued 2799 patients including 733 accrued to treatment trials.
Observational studies enrolled 656 patients, and 514 enrolled on ancillary/correlative trials. LCCC clinical trials
enroll patients from the entire state of North Carolina, our catchment area.
A unique feature of LCCC’s CPDM is the Clinical Development Team that assists investigators developing IITs
in study concept development and design, funding applications, protocol writing, and adherence to regulatory
requirements including IND support and management of FDA communications. With this team over the past 5
years we have increased our IITs by 30% and nearly doubled our LCCC-held INDs to 42. Trial review is
facilitated by our PODs, endorsed trials undergo review by the Resource and Feasibility Team (RAFT) to
ensure appropriate staffing and resources, then review by the Protocol Review Committee (PRC).Budget and
contract development occur in parallel so that IRB review and contract execution can be as close as possible.
The LCCC Data and Safety Monitoring Committee meets monthly to review trials, with the frequency of review
based on risk and complexity as determined by the LCCC PRC. The CPDM supports independent audits of our
IITs conducted by an external entity, the UNC Office of Clinical Trials (OCT). The Compliance Committee
meets monthly to review audit findings and corrective and preventive action (CAPA) plans.
UNC LCCC conducts research on minority health disparities and seeks new ways to optimize trials across
underserved groups and the lifespan. Dr. Charlot, the CPDM faculty advisor for minority accrual, is activating
plans...

## Key facts

- **NIH application ID:** 10320885
- **Project number:** 5P30CA016086-46
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Carrie B Lee
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $851,107
- **Award type:** 5
- **Project period:** 1997-06-01 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10320885

## Citation

> US National Institutes of Health, RePORTER application 10320885, Clinical Protocoal and Data Management (5P30CA016086-46). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10320885. Licensed CC0.

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