Do you or someone you know want to participate in a clinical study? See information for patients and families.
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)
New to registering studies? See For Study Record Managers.
Learn about the purpose of study registration and results submission. Includes an overview of applicable laws and policies.
Learn about Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), and the basic requirements for registering clinical trials and submitting summary results information, including information about the Responsible Party, Applicable Clinical Trials, deadlines, and penalties. The availability of the final rule for FDAAA 801, which clarifies and expands the requirements for certain clinical trials, is also described.
Learn how to apply for an account to access the Protocol Registration and Results System (PRS), the Web-based system used to submit study data to ClinicalTrials.gov.
Review the basic steps for study registration, find out what data elements are required, and learn about the record review process.
Learn about required updates, how to edit study records, and how to view earlier versions of a record.
Review the basic steps for submitting results, find out what data elements are required, and learn about the record review process.
Review frequently asked questions about PRS and entering study data.
Find data element definitions and resources related to study registration and results submission, as well as links to relevant laws and policies. Includes links to resources on external sites such as the Food and Drug Administration and International Committee of Medical Journal Editors.
View National Library of Medicine presentations and workshop materials for researchers and study record managers on submitting data to ClinicalTrials.gov and related laws and policies.