The Clinical Research Management Office (CRMO) provides infrastructure for the conduct of clinical research at the HICCC. The functions of the CRMO include: ? Facilitating the conduct of clinical research by maintaining the administrative and trial management operations, ? Working closely with Bioinformatics to ensure the optimal operation of clinical information systems and databases, and ? Providing an interface with regulatory and sponsoring agencies. To accomplish these goals, the CRMO has four offices, Research Nursing, Data Management, Research Operations and Regulatory Management, and Data Applications. Experienced senior managers head each of the four offices and the heads of the first three report to the Administrator for Research Operations. The Offices of Research Nursing and of Data Management are responsible for the assignment, supervision, and training of 12 research nurses and 28 data managers and clinical research associates who staff HICCC clinical trials. The Office of 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 7, maintains files on each protocol submitted to the CRMO, submits protocols, amendments, annual reviews and adverse drug reaction reports to the IRB and PRMC 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 reports jointly to the Director of the CRMO and to the Director of Bioinformatics and handles the informatics that includes the implementation and management of Velos, a clinical trials informatics system compatible with CaBIG. The CRMO works closely with the Protocol Review and Monitoring Committee (PRMC), with investigators, and with the Biostatistics Shared Resource to bring efficient, seamless and responsible clinical trials management to the Cancer Center. The projected operating budget of the CRMO is $517,204, of which we are requesting $249,084 from the CCSG.
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