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.
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