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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 the requirements for registering and submitting summary results information for applicable clinical trials described in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). This page includes summary information to help responsible parties understand their obligations under FDAAA 801 and the Final Rule and links to key regulatory provisions and related discussions.
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.