For Study Record Managers
Clinical studies are registered on ClinicalTrials.gov via a Web-based data entry system called the Protocol Registration and Results System (PRS).
ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:
- Any applicable human subject or ethics review regulations (or equivalent)
- 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:
- See Why Should I Register and Submit Results? to learn more about PRS and study registration policies.
- See FDAAA 801 and the Final Rule to learn about Section 801 of the Food and Drug Administration Amendments Act of 2007, which requires registration of and the submission of results for certain clinical 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.
See How to Apply for a PRS Account for information on who should apply for a PRS account and how to obtain a PRS account.
Login to PRS
Go to PRS if you:
- Are ready to enter data
- Already have an account