This CTSC workshop provides an overview of the applicable regulations for Investigator-Initiated Trials (IITs), including the role and responsibilities of the individual investigator, who acts as both an investigator and sponsor conducting the study. The seminar includes a review of the reporting requirements and essential documentation required for these trials and illustrates the risks involved. Tips to avoid the common pitfalls are addressed, including examples from Food and Drug Administration (FDA) inspections and how to prepare for a possible inspection.