The City of Hope (COH) National Medical Center and Beckman Research Institute proposes to enhance the COH research human subjects protection program by improving its ability to perform several essential administrative and data and safety monitoring functions. The project will receive overall direction and guidance from Marsha Emmer Addis, Senior Vice President for Research Operations, serving as principal Investigator, and will receive operational direction and design leadership from David N. Ikle, Ph.D., Associate Director, Department of Biostatistics, Division of Information Sciences, serving as Project Leader. Work on this project will be performed by staff from the Department of Biomedical Informatics, Division of Information Sciences, who will work together in a project team under the direction of Dr. Ikl& Overall direction and specific project objectives will be validated through the use of a Project Advisory Committee composed of representatives from the principal user communities. The overall objectives of this proposal are to: (A) Create the informatics infrastructure required to improve the efficiency and reliability of certain administrative and monitoring functions of the IRB, the CPRMC, and the Research Conflict of Interest committee; (B) Facilitate the use of electronic documents by the IRB and CPRMC for protocol review and monitoring; (C) Integrate these new informatics resources with existing related institutional information systems; (D) Improve the knowledge of IRB members in human subjects protection.
The specific aims of this proposal are to: (A) Create a new tracking system for 1) monitoring and coordinating the adverse event and protocol deviation reporting processes, 2) coordinating the review and documentation of research faculty and staff conflict of interest statements, and 3) coordinating the certification of research faculty and staff human subjects protection training; (B) Design and implement a process for the coordination and management of electronic protocol review documents between the IRB and CPRMC to improve the efficiency of the respective committee operations; (C) Create interfaces between the new tracking system and existing systems for clinical trials data management, IRB and CPRMC administration, and Human Resources management; and (D) Distribute to IRB members copies of a recent book on human subjects protection in clinical research. These enhancements to existing information infrastructure and improvements to training and certification procedures will improve the efficiency and reliability of these essential human subjects protection and data and safety monitoring functions at City of Hope.
