# Clinical Protocol and Data Management Core

> **NIH NIH P30** · H. LEE MOFFITT CANCER CTR & RES INST · 2020 · $237,496

## Abstract

Clinical Protocol & Data Management 
PROJECT SUMMARY 
Clinical Protocol & Data Management (CPDM) functions at Moffitt Cancer Center (MCC) include 1) trial design, 
development, and conduct; 2) oversight of safety and compliance; 3) ensuring data quality and education of 
personnel; and 4) appropriate accrual of women and minorities. A collaborative team of approximately 190 
CPDM professionals provides centralized management and support of all types of clinical trials, including 
investigator-initiated (IITs), industry or other sponsor-initiated, Experimental Therapeutics Clinical Trials 
Network (ET-CTN), and National Clinical Trials Network (NCTN). CPDM support for members includes: 
protocol development; budget development and contracting; regulatory and IND/IDE management; protocol 
activation; patient enrollment; coordination of study-related patient care; research drug administration and care 
services; correlative science (pharmacokinetics/pharmacodynamics) sample coordination; data collection and 
reporting; monitoring of IIT studies and data and safety monitoring through the Protocol Monitoring Committee 
(PMC) and Data Safety & Monitoring (DSM) Committee; audit preparation and coordination; minority outreach 
and navigation for accrual to clinical trials; clinical trials management system (CTMS, OnCore) administration 
and reporting; staff workload management; and staff education and training. 
During the review period (FY2011-2015), the CPDM team successfully accrued and coordinated a combined 
total of 11,851 patients to clinical interventional trials (therapeutic, prevention, and supportive care), including 
accrual at affiliate sites. 
CPDM provides centralized safety and compliance oversight to members through timely monitoring of 
investigator-initiated interventional trials, coordination of the PMC, and corporate compliance audits of MCC 
clinical research trials, policies, and processes. Results of monitoring and audits are utilized by the PMC for 
comprehensive review. 
MCC has developed and maintains proactive efforts to provide programs and services to women, minorities, 
and other underserved populations through culturally and linguistically relevant care, education, and internal 
and community outreach. Faculty members conduct research on minority health disparities, informing these 
programs and services. In addition, the ACD for Clinical Science and the VP of Diversity and Community 
Relations co-lead a multi-disciplinary Minority Clinical Research Committee to address issues related to 
minority accrual at MCC. CPDM resources are closely integrated in these efforts.

## Key facts

- **NIH application ID:** 9868924
- **Project number:** 5P30CA076292-22
- **Recipient organization:** H. LEE MOFFITT CANCER CTR & RES INST
- **Principal Investigator:** Hatem H Soliman
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $237,496
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9868924

## Citation

> US National Institutes of Health, RePORTER application 9868924, Clinical Protocol and Data Management Core (5P30CA076292-22). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9868924. Licensed CC0.

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