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 early 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 study specific 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.
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