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# Guide on ClinicalTrials.gov Civil Money Fines
- URL: https://www.fdaweb.com/guide-on-clinicaltrials-gov-civil-money-fines/
- Published: 2020-08-14T12:00:00.000Z
- Updated: 2026-09-14T16:25:04.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147431

FDA has issued a [final guidance](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-17909.pdf?ref=fdaweb.com) entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The document outlines how the agency plans to identify whether responsible parties have failed to submit required clinical trial registration or results information to ClinicalTrials.gov. It also discusses how it will identify whether parties have submitted false or misleading information to the data bank or if they have failed to submit or knowingly submitted a false certification to the agency. Additionally, the guidance describes the circumstances under which FDA may decide to seek civil money penalties for noncompliance, the applicable procedures for assessing civil money penalties, and the civil money penalty amounts that may be assessed for violations related to the ClinicalTrials.gov submission requirements.