# Clinical Protocol and Data Management

> **NIH NIH P30** · GEORGETOWN UNIVERSITY · 2022 · $134,315

## Abstract

ABSTRACT
Organizational efforts for Georgetown Lombardi Comprehensive Cancer Center (LCCC) clinical trials are
focused at three sites: MedStar Georgetown University Hospital (MGUH) and MedStar Washington Hospital
Center (MWHC) in Washington DC and the John Theurer Cancer Center (JTCC) in Hackensack, NJ. The
JTCC Clinical Trials Office was added in 2014 after the 2013 signing of a Cancer Center Affiliation Agreement
between LCCC and JTCC to work toward becoming a formal National Cancer Institute (NCI)–designated
Consortium Cancer Center. The Clinical Research Management Office (CRMO) provides central management
and oversight for coordinating, facilitating and reporting on LCCC clinical trials. CRMO Administrative Directors
Radakovic (DC) and Richards (NJ) have extensive clinical research experience and report directly to the
Medical Directors, Pishvaian (DC) and Goy (NJ) and through them to Giaccone, the Associate Director (AD)
for Clinical Research. All are responsible for supervising personnel and procedures at their specific sites. The
organization is supported by eight cross-institutional disease groups (DGs), which discuss, select and
promulgate trial opportunities and employ a common Protocol Review and Monitoring System (PRMS). In
addition, all investigator-initiated trials (IITs) are subject to oversight by a common Data Safety Monitoring
Committee (DSMC). Within the CRMO, the Research Nursing and Data Management (RNDM) Offices are
responsible for assigning, supervising and training the research nurses, study coordinators, data managers
and lab technicians who staff therapeutic clinical trials. The Regulatory Management Office maintains
regulatory binders for each protocol; submits protocols, amendments, annual reviews and adverse drug
reaction reports to various regulatory authorities and maintains current copies of open protocols on a
password-protected web site for investigators and staff. This effort has been greatly facilitated by the recent
acquisition and implementation of a new Clinical Trials Management System (CTMS): OnCore Enterprise
Research. The Quality Assurance Office (QAO) is responsible for compliance, monitoring activities and
providing administrative and audit support to the DSMC. It also assists in staff training and educational
activities. A recently formed Multi-Center Project Management Office is responsible for coordinating LCCC-
led multisite IITs. Management teams for each site meet biweekly by conference call and quarterly in person to
create joint standard operating procedures (SOPs). The Data Applications Group handles informatics,
including the creation of electronic case report forms (eCRFs) for all IITs (now on OnCore) and maintenance of
the OnCore database, which contains information about each protocol, to allow study submission to the NCI
Clinical Trials Reporting Program (CTRP) for the generation of Data Table 4 and study-specific accrual reports.
The DSMC is chaired by Dawson and oversees the NCI-approv...

## Key facts

- **NIH application ID:** 10400663
- **Project number:** 5P30CA051008-29
- **Recipient organization:** GEORGETOWN UNIVERSITY
- **Principal Investigator:** Michael J Pishvaian
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $134,315
- **Award type:** 5
- **Project period:** 1997-08-15 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10400663

## Citation

> US National Institutes of Health, RePORTER application 10400663, Clinical Protocol and Data Management (5P30CA051008-29). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10400663. Licensed CC0.

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