# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF MARYLAND BALTIMORE · 2020 · $124,821

## Abstract

12.0 Abstract: Clinical Protocol and Data Management 
The Clinical Protocol and Data Management (CPDM) component of UMGCC comprises the personnel in the 
Clinical Research Management Office (CRMO), formerly defined as the Clinical Research Shared Service in 
the 2011 CCSG application, and the resources, including database and technical staff, supporting its 
operations. The CRMO participates with investigators in the various UMGCC Disease Groups or assists 
research support staff housed in other departments in UMB, as requested, in the design, review, 
implementation, monitoring, and reporting of all clinical protocols. This effort includes interactions with the 
Institutional Review Board (IRB) of UMB, the NCI Central IRB, the Clinical Research Committee (CRC; 
functioning as the Protocol Review and Monitoring System) of UMGCC, and the UMGCC Data Safety 
Monitoring/Quality Assurance Committee (DSM/QAC) as well as other monitoring and auditing entities. CRMO 
utilizes the OnCore database to track enrollment of all patients, completing case report forms for industry- 
sponsored trials and entering data into appropriate databases for National Clinical Trials Network and 
Experimental Therapeutics Clinical Trials Network NCI-sponsored studies. 
During the last granting period encompassing CY2010–2014, the CRMO supported 200–250 protocols/year, 
resulting in 112 publications. The UMGCC DSM/QAC serves the data safety monitoring function for those 
protocols that do not have an external data and safety monitoring board (DSMB). The DSM/QAC annually 
reviews safety information for accrued patients to all “greater than minimal risk” (according to UMB IRB criteria) 
investigator-initiated trials of any phase, all Phase I trials, and selected industry Phase II trials without a 
sponsor-appointed DSMB, including multi-institutional investigator-initiated trials for which UMGCC is the 
coordinating center. During FY2014, costs to support CPDM were $3,159,534, of which $157,278 were from 
the CCSG. During FY2014, costs to support the DSM/QAC were $776,002, of which $78,500 were from the 
CCSG.

## Key facts

- **NIH application ID:** 9984996
- **Project number:** 5P30CA134274-13
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Ashkan Emadi
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $124,821
- **Award type:** 5
- **Project period:** 2008-08-08 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9984996

## Citation

> US National Institutes of Health, RePORTER application 9984996, Clinical Protocol and Data Management (5P30CA134274-13). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9984996. Licensed CC0.

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