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-approved plan.
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