"Applicable clinical trials" generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).
Protocol Registration System Information
Organizations and investigators wishing to register trials must first apply for a PRS account via the links provided below. Within two business days, ClinicalTrials.gov will create the account and send email with instructions on how to login to the PRS, so that you can register your trials.
There are two types of PRS accounts: