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        Clinical Trials and Human Subject Protection

FDA's Role: ClinicalTrials.gov Information

                        
                Pre-Notices for Potential Noncompliance
          ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions Home
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          Clinical Trials and Human Subject Protection
          FDA's Role: ClinicalTrials.gov InformationClinical Trials and Human Subject Protection FDA's Role: ClinicalTrials.gov Information
  	
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    PrintFederal law requires responsible parties to register with and submit results information to the ClinicalTrials.gov data bank for certain applicable clinical trials.

Transparency of clinical trial information is important to scientific advancement. Registering certain trials and posting summary results information permits the scientific community to build on the information made available. The public’s participation in clinical trials makes it possible to further advance scientific progress. Posting clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results.

Federal law requires:

A certification of compliance with ClinicalTrials.gov requirements to accompany certain human drug, biological product and device applications and submissions to FDA.
	The inclusion of a particular statement (see below) in the informed consent documents for applicable clinical trials, which are trials that will be entered into the ClinicalTrials.gov databank.
	FDA to oversee compliance and take appropriate enforcement action related to failure to submit required clinical trial information to ClinicalTrials.gov.Requirements for Certification of Compliance with Certain Product Applications

FDA developed Form FDA 3674 which may be used to provide certification. The certification must accompany certain human drug, biological product and device applications and submissions. In general, FDA recommends that Form FDA 3674 accompany the following applications and submissions to FDA:

Investigational New Drug Application (IND)
	New Clinical Protocol Submitted to an IND
	New Drug Application (NDA)
	Efficacy Supplement to an Approved NDA
	Biologics License Application (BLA)
	Efficacy Supplement to an Approved BLA
	Abbreviated New Drug Application (ANDA)
	Premarket Approval Application (PMA)
	PMA Panel Track Supplement
	Humanitarian Device Exemption (HDE)
	510(k) submissions that refer to, relate to or include information on a clinical trialFederal law does not require the submission of a Form FDA 3674 with an Investigational Device Exemption (IDE) application.

More information is available in FDA Guidance on Form FDA 3674.

Informed Consent Requirements

Federal law requires the following exact statement to be included in the informed consent documents of applicable clinical trials:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

See FDA’s guidance on Informed Consent Elements, 21 CFR 50.25(c) for more information.

ClinicalTrials.gov Compliance and Enforcement Activities

The FDA’s compliance activities related to the ClinicalTrials.gov requirements provide the opportunity for responsible parties to take voluntary corrective actions before the agency proceeds with enforcement action. The agency uses a risk-based approach to compliance and enforcement to prioritize the greatest risks to public health.

The final guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank outlines FDA’s approach to its compliance and enforcement activities related to ClinicalTrials.gov, including potential civil money penalties for violations.

See pre-notices of noncompliance and notices of noncompliance for more information.

Questions Related to ClinicalTrials.gov

See Submit Studies to ClinicalTrials.gov PRS for information about registering clinical trials on ClinicalTrials.gov. Contact register@clinicaltrials.gov with questions related to:

Regulations at 42 CFR Part 11
	How to register studies and how to submit clinical trial results information
	Technical issues related to submission of information to the ClinicalTrials.gov databankContact gcpquestions@fda.hhs.gov with questions about compliance and enforcement of ClinicalTrials.gov requirements.

Complaints to FDA should be reported to the office handling the type of study involved. See FDA contact information for complaints.

Additional resources

ClinicalTrials.gov – a Three-Part Series
	Final Rule on Clinical Trials Registration and Results Information Submission
	ClinicalTrials.gov - Pre-Notices for Potential Noncompliance
	ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions
	ClinicalTrials.gov regulations (42 CFR Part 11)
	Details of the statutory language of Title VIII of FDAAA
	NIH Checklist for evaluating whether a clinical trial is an applicable clinical trial
	Form FDA 3674 (including instructions)
	FDA Guidance on Form FDA 3674
	FDA Guidance on Informed Consent Elements at 21 CFR 50.25(c)
	FDA guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

                                                                                  Content current as of:
      12/04/2023FDA's Role: ClinicalTrials.gov Information                
                          

                        Pre-Notices for Potential Noncompliance
          ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions
 
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