# Clinical Protocol and Data Management (Core 018)

> **NIH NIH P30** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $689,776

## Abstract

Abstract - Clinical Protocol and Data Management (CPDM) 
The Clinical Protocol and Data Management component includes the Clinical Protocol Office (CPO), the 
clinical data management team, and the compliance committees (Audit; Data and Safety Monitoring). These 
integrated groups provide centralized management and oversight for cancer clinical trials conducted by 
members of the UNC Lineberger Comprehensive Cancer Center (LCCC). 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 National Clinical Trials Network groups and the 
Experimental Therapeutics Clinical Trials Network. The CPO centralizes the protocol registration, regulatory 
affairs, compliance committee work, management of clinical trials, and facilitates efficient and effective training 
for research personnel and timely activation of protocols in support of cancer center investigators from all 
relevant disciplines. Investigator-initiated protocol development is facilitated by dedicated specialists who work 
with investigators. Claire Dees serves as Medical Director of the CPO and chairs the Protocol Office Executive 
Committee, which is comprised of the disease-specific Protocol Office Disease Group faculty leaders. Carrie 
Lee and Jared Weiss provide additional faculty leadership with responsibility for operations and finance. 
The accrual to all intervention trials at UNC in 2014 was 1731 patients. Accrual to treatment interventions at 
UNC was 604 cancer patients. Observational studies enrolled 4790 subjects and 572 were accrued to ancillary 
or correlative trials at UNC. The total UNC accrual to studies of all types was 7093 subjects. Affiliate sites 
accrued 450 subjects to UNC IITs. 
The CPDM audits investigator-initiated and NCI-funded therapeutic trials to authenticate compliance and 
capture of accurate data through its Audit Subcommittee. The Audit Subcommittee meets following the monthly 
audit to review findings from the audit. Audit findings are addressed directly to the Principal Investigator, with a 
summary being issued to the Principal Investigator and the Protocol Review Committee. The Data Safety and 
Monitoring Committee reviews trials on a regular (quarterly to annually) basis, with the frequency of review 
based on risk and complexity as determined by the LCCC Protocol Review Committee. 
The UNC Lineberger conducts research on minority health disparities and continually seeks new ways to 
optimize accrual of women and minorities to trials. Dr. Wendy Brewster serves as Faculty Advisor for Minority 
Accrual. Initiatives to facilitate minority accrual include a dedicated interpreter and modification of our clinical 
trial prioritization checklist to specify minority and female target accrual, which will generate information needed 
to identify obstacles to accrual. We are also exploring options to use Ep...

## Key facts

- **NIH application ID:** 9834866
- **Project number:** 5P30CA016086-44
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** ELIZABETH CLAIRE DEES
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $689,776
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9834866

## Citation

> US National Institutes of Health, RePORTER application 9834866, Clinical Protocol and Data Management (Core 018) (5P30CA016086-44). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9834866. Licensed CC0.

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