Specific Aims: The University of Southern California (USC) and its affiliated hospital partner, Childrens Hospital Los Angeles (CHLA) will collaborate to develop the University of Southern California and Childrens Hospital of Los Angeles IRB Submission and Review System, (SCCISARS), that will be utilized by both institutions to reduce the review cycle time and enhance protocol monitoring, while simultaneously educating researchers and IRB members. SCCISARS will: (1) Enhance regulatory compliance by automating the UPC-IRB, HSC-IRB and CCI (collectively IRB/CCI) application, review and approval process; (2) Provide education to investigators by giving them instant """"""""real time"""""""" information applicable to the specific protocol being submitted; (3) Increase awareness of and compliance with regulations governing human subjects in research by explaining the regulations; (4) Promote coordination and uniformity between and among the IRB/CCI at USC and CHLA by standardizing common aspects of the IRB/CCI application, review and approval process; and through the sharing of information, special skills and expertise; (5) Encourage and enhance collaboration between investigators conducting human subjects research at USC and CHLA by creating a more uniform and consistent administrative process for faculty who may """"""""cross"""""""" the institutional boundaries in the conduct of their research; (6) Reduce IRB/CCI staff time devoted to paper shuffling, thereby permitting a greater focus on issues generated by higher risk protocols and the protection of human research subjects in general; (7) Facilitate investigator notification to the IRB/CCI of adverse events and other potential dangers to human subjects and facilitate the IRB/CCI review of and response to such events. Research Desiqn and Methods: SCClSARS will consist of a WEB based application that the investigator will use in submitting projects for IRB/CCl review. Investigators will be able to input, save and edit the electronic web application, which will be similar for all IRB/CCIs. The system will provide relevant information and education to the Investigators as they are completing the application process. The Investigator will submit the application and supporting documents electronically, which will be routed to the appropriate IRB/CCl populating the internal IRB/CCl SQL database. SCClSARS will generate review forms for routing with the submitted materials to primary reviewers and IRB/CCl members. SCClSARS will generate correspondence to investigators and minutes and Investigators can track the status of their application using the system. Documents will be made available to investigators and staff on SCCISARS Document Resource Center. Components of SCClSARS will permit investigators to provide immediate information regarding severe adverse events that must be reported to the appropriate IRB/CCl and regulatory agencies. SCClSARS also will accommodate the collection of additional information, such as information relating to the composition of DSMBs for Phase III clinical trials and safety monitoring plans for Phase I and II clinical trials.
