Clinical Protocol and Data Management / Clinical Trials Office/Data and Safety Monitoring The integrated Clinical Research Management Office (iCRMO) provides infrastructure for the conduct of Georgetown Lombardi Comprehensive Cancer Center (LCCC) clinical research throughout the MedStar Georgetown Cancer Network (MGCN). MGCN was formed in 2012 and the CRMO was reorganized in eariy 2013 as the ICRMO to support the expanded Network. CCSG clinical research within MGCN is confined to MedStar Georgetown University Hospital (MGUH), MedStar Washington Hospital Center (MWHC) and MedStar Montgomery Medical Center (MMMC) with other MedStar hospitals being considered affiliates. The iCRMO provides central management and oversight for coordinating, facilitating and reporting on cancer clinical trials. iCRMO Administrative Directors Levy and Montalvo have extensive clinical research experience and report directly to Giaccone, Associate Director for Clinical Research. Medical Directors, Dawson, Perry and Noga are responsible for supervising personnel and procedures at their specific MGCN sites. Within the iCRMO, the Research Nursing and Data Management (RNDM) Offices are responsible for the assignment, supervision and training of research nurses, study coordinators, data managers and lab technicians who staff therapeutic clinical trials throughout the MGCN. 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. The Quality Assurance Office is responsible for compliance and monitoring activities, multisite coordination of investigator-initiated trials and providing administrative and audit support to the Data Safety and Monitoring Committee (DSMC). It also assists in staff training and educational activities. Data Applications Group handles informatics that include creation of electronic case report forms for all investigator-initiated trials and maintenance of an Oracle APEX database that contains information about each protocol to allow the generation of Data Table 4 and studyspecific accrual reports. The DSMC is chaired by Deeken and oversees the NCI-approved plan. The iCRMO works closely with the Protocol Review and Monitoring System (PRMS), DSMC, IRB, disease groups, and Biostatistics &Bioinformatics Shared Resource to bring efficient, seamless and responsible clinical trials management to LCCC.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA051008-21
Application #
8698921
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-08-15
Project End
2019-04-30
Budget Start
2014-09-09
Budget End
2015-04-30
Support Year
21
Fiscal Year
2014
Total Cost
$60,278
Indirect Cost
$21,514
Name
Georgetown University
Department
Type
DUNS #
049515844
City
Washington
State
DC
Country
United States
Zip Code
20057
Bae, Woo Kyun; Yoo, Kyung Hyun; Lee, Ji Shin et al. (2015) The methyltransferase EZH2 is not required for mammary cancer development, although high EZH2 and low H3K27me3 correlate with poor prognosis of ER-positive breast cancers. Mol Carcinog 54:1172-80
Adams, Inez; Christopher, Juleen; Williams, Karen Patricia et al. (2015) What Black Women Know and Want to Know About Counseling and Testing for BRCA1/2. J Cancer Educ 30:344-52
Butrick, Morgan; Kelly, Scott; Peshkin, Beth N et al. (2015) Disparities in uptake of BRCA1/2 genetic testing in a randomized trial of telephone counseling. Genet Med 17:467-75
London, Laricca; Hurtado-de-Mendoza, Alejandra; Song, Minna et al. (2015) Motivators and barriers to Latinas' participation in clinical trials: the role of contextual factors. Contemp Clin Trials 40:74-80
Mays, Darren; Niaura, Raymond S; Evans, W Douglas et al. (2015) Cigarette packaging and health warnings: the impact of plain packaging and message framing on young smokers. Tob Control 24:e87-92
Zhi, Xiuling; Lin, Ling; Yang, Shaoxian et al. (2015) ?II-Spectrin (SPTBN1) suppresses progression of hepatocellular carcinoma and Wnt signaling by regulation of Wnt inhibitor kallistatin. Hepatology 61:598-612
Rush, Christina L; Darling, Margaret; Elliott, Maria Gloria et al. (2015) Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention. Qual Life Res 24:1107-18
Heckler, Mary Mazzotta; Riggins, Rebecca B (2015) ERR? splice variants differentially regulate cell cycle progression. Cell Cycle 14:31-45
Kim, B; Wang, S; Lee, J M et al. (2015) Synthetic lethal screening reveals FGFR as one of the combinatorial targets to overcome resistance to Met-targeted therapy. Oncogene 34:1083-93
Tong, Angie; Kelly, Scott; Nusbaum, Rachel et al. (2015) Intentions for risk-reducing surgery among high-risk women referred for BRCA1/BRCA2 genetic counseling. Psychooncology 24:33-9

Showing the most recent 10 out of 544 publications