Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. NIH INTRAMURAL-IRB AND CLINICAL DIRECTOR (CD) REPORTING 7.2.1 NIH Intramural IRB and NCI CD Expedite d Reporting of Unanticipated Problems and Deaths The protocol PI will report in the NIH Problem Form to the NIH Intramural IRB and NCI Clinical Director: x All deaths, except deaths due to progressive disease Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 45x All protocol deviations x All unanticipated problems x All non-compliance Reports must be received within 7 days of PI awareness via iRIS. 7.2.2 NIH Intramural IRB Requirements for PI Reporting at Continuing Review The protocol PI will report to the NIH Intramural IRB: 1. A summary of all protocol deviations in a ta bular format to include the date the deviation occurred, a brief description of th e deviation, and any corrective action.