For Study Record Managers
Clinical studies are registered with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS).
ClinicalTrials.gov allows the registration of clinical studies with human subjects that conform to:
- Any applicable human subject or ethics review regulations (or equivalent) and
- Any applicable regulations of the national or regional health authority (or equivalent)
The Submit Studies section has information and instructions for data providers, sponsors, and study investigators, including:
- See Why Should I Register and Submit Results? to learn more about PRS and study registration policies.
- See FDAAA 801 Requirements to learn about Section 801 of the Food and Drug Administration Amendments Act of 2007, which requires clinical trial registration and the submission of results of certain trials.
Get an account
ClinicalTrials.gov establishes one PRS account for an organization (such as a company, university, or medical center). Each PRS account is managed by one or more administrators who may add an unlimited number of user logins.
You must have a PRS account to register a clinical study or submit results information for a registered study.
Please see How to Apply for an Account for information on who should apply for a PRS account and how to obtain a PRS account.
Login to PRS
Go to the Protocol Registration System (PRS) if you:
- Are ready to enter data
- Already have an account