ClinicalTrials.gov is a database of information on ongoing and completed clinical studies. U.S. laws and other policies specify what information must be provided and for which studies. For more information, see U.S. Laws, Regulations, and Guidance.

Information about a clinical study is submitted by the responsible party to ClinicalTrials.gov via the interactive Web-based Protocol Registration and Results System (PRS) or by uploading XML files to the PRS. Details on the data elements and XML formats are provided below:

Protocol Registration Information

• Protocol Registration Data Element Definitions: Describe the registration data items (required and optional) that are entered via PRS
• Expanded Access Data Element Definitions: Describe the expanded access data items (required and optional) that are entered via PRS
• The ClinicalTrials.gov PRS Protocol Schema describes the XML format suitable for uploading the protocol registration data elements.

Results Information

• Results Data Element Definitions: Describe the results data items (required and optional) that are entered via PRS
• ClinicalTrials.gov PRS Results Schema: Describes the XML format suitable for uploading the results data elements

For more details on submitting information to ClinicalTrials.gov, see the Submit Studies section of the site.

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