# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF MARYLAND BALTIMORE · 2022 · $274,032

## Abstract

7.0. Abstract: Clinical Protocol and Data Management
Clinical Protocol and Data Management (CPDM): The Clinical Research Management Office (CRMO)
provides clinical trial management services to more than 35 investigators and oversees high-quality conduct and
reporting of all cancer clinical trials at the University of Maryland Marlene and Stewart Greenebaum
Comprehensive Cancer Center (UMGCCC) and the University of Maryland network sites. Comprising more than
50 full-time equivalent personnel, CRMO works closely with UMGCCC Disease/Modality Focused Groups (DFG)
to manage a robust cancer clinical trial portfolio that prioritizes institutionally and externally peer-reviewed trials
and complements UMGCCC's patient catchment area. CRMO utilizes the OnCore® database to track the
conduct of and patient accrual to all oncology clinical trials and to centrally report clinical research activities to
UMGCCC leadership. During the last grant period (CY2015–2019), CRMO supported the activation of 381
interventional clinical trials, resulting in 2,029 interventional trial enrollments during the reporting period. During
FY2019, costs to support CPDM were $4,569,709, of which $204,148 were funded by the CCSG. Data and
Safety Monitoring: UMGCCC's Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) serves the
data safety monitoring function for protocols that do not have an external data and safety monitoring board
(DSMB). The DSM/QAC annually reviews safety information for patients accrued to all oncology protocols
considered “greater than minimal risk,” as defined in the UMGCCC-approved DSM Plan. This includes
investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a sponsor-
appointed DSMB, as well as multi-institutional, investigator-initiated trials for which UMGCCC is the coordinating
center. During FY2019, costs to support DSM/QAC were $93,938, of which $23,592 were funded by the CCSG.
This funding supported the annual review of 344 trials during the reporting period, as well as a percentage of
salaries for three staff members. Inclusion of Women and Minorities in Clinical Research: UMGCCC
continues to demonstrate a robust enrollment of women and minorities into clinical trials. Among the 2,029 people
enrolled into interventional trials from CY2015–CY2019, 1,146 (56 percent) were women. Overall minority
accrual to clinical trials is 56 percent. This includes 48.2 percent underrepresented minorities as well as 7.8
percent Asians, the latter reflecting clinical trials examining health disparities in that group. Underrepresented
minority accrual to therapeutic trials is 34.7 percent. Inclusion of Individuals Across the Life Span in Clinical
Research: UMGCCC is strongly committed to including individuals across the life span into clinical research. Of
the 2,029 people enrolled into interventional trials from CY2015–CY2019, 448 (22 percent) were older than 65
years of age, and an average of 17 percen...

## Key facts

- **NIH application ID:** 10492064
- **Project number:** 5P30CA134274-15
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Ashkan Emadi
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $274,032
- **Award type:** 5
- **Project period:** 2008-08-08 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10492064

## Citation

> US National Institutes of Health, RePORTER application 10492064, Clinical Protocol and Data Management (5P30CA134274-15). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10492064. Licensed CC0.

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