Creation of a Secured IRB Protocol Management System

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Duke University Heatlh System administers over 2400 IRB protocols annually. Duke's MPA includes responsibility for investigators in three hospitals in its system and in clinic sites throughout the region. Currently, five IRBs review and monitor these protocol. Furthermore, investigators are frequently working away from their offices and need to have access to the IRB system and their protocols. Since the number of clinical trials under active IRB review continues to grow at a rapid rate, the IRB report management system at Duke must be improved and expanded. We also anticipate increased work for the IRBs associated with HIPAA implementation. In order to deal with these demands on the IRB, we must create new facilities and systems to meet our needs. Duke University Health System proposes to meet these needs through three approaches. First, the institution will increase the number of IRBs from 5 to 6. This increase in the number of IRBs and the large activity level of the current IRBs requires that we create new facilities to accommodate this level of activity. This will also require that secure space be developed for the confidential handling and storage of IRB protocols. We propose to use this support to create a secure storage unit in the new IRB office for both records and the computer server. Second, we intend to develop a secure, web based electronic IRB submission and tracking system. The system will permit the management of new protocols and those undergoing continuing review, the recording of adverse events, amendments, and audit reports, documentation of educational training and credentialing, and development of Phase 1/11data and safety monitoring plans. The elRB system will also permit more efficient communication among the conflict of interest committee, the Grants office, and the IRB. We are requesting funds to create and implement such a system. Finally, we propose to develop a training program for the users of the system which will include a module focusing on the unique challlenges of protecting subject privacy and data confidentiality when using an electronic database. We believe that these initiatives will both improve the protection of human research subjects but will also enhance the effeciency of the IRB review process and promote clinical research at Duke.