The Clinical Research Management Office (CRMO) provides infrastructure for the conduct of clinicalresearch at the HICCC. The functions of the CRMO include: Facilitating the conduct of clinical research by maintaining the administrative and trial managementoperations, Working closely with Bioinformatics to ensure the optimal operation of clinical information systemsand databases, and Providing an interface with regulatory and sponsoring agencies.To accomplish these goals, the CRMO has four offices, Research Nursing, Data Management, ResearchOperations and Regulatory Management, and Data Applications. Experienced senior managers head eachof the four offices and the heads of the first three report to the Administrator for Research Operations. TheOffices 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 staffHICCC clinical trials. The Office of Data Management is also responsible for audit compliance and qualityassurance. The office of Research Operations and Regulatory Management, with a supervisor and astaff of 7, maintains files on each protocol submitted to the CRMO, submits protocols, amendments, annualreviews and adverse drug reaction reports to the IRB and PRMC and maintains current copies of openprotocols on a password protected website for investigators and staff. The office is also responsible foroversight of quality control of the CRMO and implementation of new procedures. The Data ApplicationsGroup reports jointly to the Director of the CRMO and to the Director of Bioinformatics and handles theinformatics that includes the implementation and management of Velos, a clinical trials informatics systemcompatible 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 andresponsible clinical trials management to the Cancer Center. The projected operating budget of the CRMOis $517,204, of which we are requesting $249,084 from the CCSG.
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