We propose to strengthen our Human Subjects Protections Program in the following ways: 1. We will develop mandated educational web-based training initiatives for investigators, coordinators and Institutional Review Board (IRB) members in Data Safety Monitoring and Adverse Event Reporting. 2. We will create a system for tracking, monitoring and coordinating adverse event reports. 3. We will develop tools to link the National Jewish IRB, the proposed Data Safety Monitoring Committee (DSMC), the General Clinical Research Center (GCRC), the hospital compliance staff and other relevant institutional committees - as well as GCRCs and IRBs at other institutions - to improve standardization and avoid duplication for more efficient use of resources. These tools will provide more consistent standards fostering better compliance. 4. We will improve IRB efficiency by standardizing forms and procedures as well as completing the data entry for computer tracking of all ongoing studies into a database management system. To accomplish these goals we will develop and implement two major initiatives: 1. Establish a Data Safety and Monitoring Committee that will provide education and oversight for all ongoing studies at National Jewish. 2. Develop a Quality Assessment and Assurance Program, in conjunction with the DSMC, to assess IRB and investigator compliance with federal regulations (including on-site protocol monitoring) and to improve the efficiency of the IRB.
