The course will begin by covering TLFs, including adverse events (by System Organ Class and Preferred Term), clinical laboratory tables, efficacy tables including Swimlane plots, waterfall plots, and Spider plots for oncology, disposition, demographics, RECIST v1.1 efficacy endpoints, and other common TLFs. The course will also cover Sample Size/Power calculations for continuous, count, binary, and proportional endpoints, time to event endpoints, and group sequential trials.