Before beginning the application process for a clinical trial, it's important to determine if your study requires approval from the U.S. Food and Drug Administration (FDA). Generally, any clinical trial that involves testing a new drug, biologic, or medical device will require FDA approval. However, some studies may be exempt from FDA regulation if they involve only minimal risk to participants or if they are conducted for educational purposes. It's important to consult with an experienced clinical research professional or regulatory expert to determine if your study requires FDA approval.