The Clinical Research Management Office (CRMO) is the shared resource that provides infrastructure for the conduct of clinical research at the Lombardi Comprehensive Cancer Center (Lombardi). The functions of the CRMO are to facilitate the conduct of clinical research by maintaining the administrative and trial management operations for clinical researchers and providing an interface with regulatory and sponsoring agencies. The Director of the CRMO, Nancy Dawson, MD, has extensive experience in administration and is active in the conduct of clinical research. The CRMO comprises three divisions: Research Nursing and Data Management, Research Operations and Regulatory Management, and the Data Applications Group. An experienced senior individual who reports to the Director of the CRMO heads each division. The Research Nursing and Data Management Office is responsible for the assignment, supervision, and training of seven research nurses, four study coordinators, nine data managers and one lab technician who staff Lombardi clinical treatment trials. The Supervisor of Research Nursing and Data Management is also responsible for audit compliance and quality assurance. The office of Research Operations and Regulatory Management, with a supervisor and a staff of four, maintains files on each protocol submitted to the CRMO, submits protocols, amendments, annual reviews and adverse drug reaction reports to the IRB and Clinical Research Committee (CRC) and maintains current copies of open protocols on a password-protected website for investigators and staff. The office is also responsible for oversight of quality control of the CRMO and implementation of new procedures. The Data Applications Group handles the informatics that includes an Oracle-based system that contains protocol entry and exit information and demographic data on each patient who enters a clinical protocol and is the repository for all data for Lombardi single-institution trials. Because of our Oracle expertise we have played an important implementation role for Oracle Clinical as a caBIG adapter site. The CRMO works closely with the CRC, the Data Safety Monitoring Committee (DSMC), investigators, the Biostatistics and Bioinformatics Shared Resource, with the Lombardi MedStar Network, and the CALGB to bring efficient, seamless and responsible clinical trials management to the Cancer Center.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA051008-20
Application #
8739834
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-08-15
Project End
2014-04-30
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
20
Fiscal Year
2013
Total Cost
$43,197
Indirect Cost
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