Building Your Clinical Trial Research Team -- Clinical Trials: Ensuring Quality and Standardization -- Statistics: Setting the Stage -- Clinical Trials: Handling the Data -- Data Safety Monitoring Boards -- Planning for Data Monitoring and Audits -- The Budget -- Regulatory Considerations in Human Subjects Research -- Publishing a Clinical Trial -- Device Versus Drug Clinical Trials: Similarities and Important Differences -- Defining the Study Cohort: Inclusion and Exclusion Criteria -- The History of Clinical Trials -- Ethics of Clinical Trials -- Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design)