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Understanding the Department of Health and Human Services (DHHS) Final Rule and the National Institutes of Health (NIH) Policy for registration and study results submission to the ClinicalTrials.gov public registry

 

What is the ClinicalTrials.gov public registry?

ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. The purpose of ClinicalTrials.gov is to disclose key information about clinical trials that are currently available or that have been conducted. ClinicalTrials.gov captures significant summary protocol information before and during the trial as well as summary results and adverse event information of a completed trial.  Federal laws and regulations, as well as editors of prominent medical journals, require registration and study results submission of a clinical trial.

 

 

The Regulation and Policy that mandates registration and study results submission to the ClinicalTrials.gov public registry

1.On September 2016, the Department of Health and Human Services published a Final Rule for Clinical Trials Registration and Results Information Submission, with an effective compliance date of January 2017.

a.The key elements of the Final Rule are:

i.Those that meet the definition of a Responsible Party are required to register on clinicaltrials.gov the applicable clinical trial within 21 days after the enrollment of the first research participant, and to submit study results to the clinicaltrials.gov registry within 12 months after completion of the clinical trial.

ii.An Applicable Clinical Trial is defined as:

1.Drugs/Biologics:  Controlled clinical investigations of drugs or biological products subject to Food and Drug Administration (FDA) regulation (except for phase 1 studies).

OR

2.Medical Devices:  Controlled device trials subject to FDA regulation involving health-related outcomes (except for small feasibility studies); and, a pediatric postmarket surveillance of a device product, as required by the FDA. 

3.The trial is conducted at one or more sites in the United States.

4.The trial is conducted under an FDA IND (investigational new drug application) or IDE (investigational device exemption).

5.The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research.

6.Note:  Although Expanded AccessUse is not considered an applicable clinical trial, information on the availability of investigational drug products for expanded access will continue to be required to be submitted to clinicaltrials.gov.

2.On September 2016, the National Institutes of Health published a policy on the Dissemination of NIH-Funded Clinical Trial Information, with an effective compliance date of January 2017.

a.The key elements of the Policy are:

i.Those that meet the definition of a Responsible Party are required to register the NIH-funded clinical trials on clinicaltrials.gov within 21 days after the enrollment of the first research participant, and to submit study results to the clinicaltrials.gov registry within 12 months after completion of the clinical trial.

ii.The NIH definition of a clinical trial is:  a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

1.The above definition also includes:

a.Phase 1 trials of FDA-regulated drugs and biological products

b.Small feasibility studies of FDA-regulated device products

c.Studying healthy research participants

d.A non-comparison research design

e.A research design only to assess pharmacokinetics, safety, or maximum tolerated dose of an investigational drug

f.A research design that uses a behavioral intervention

g.Mechanistic exploratory studies

What are the consequences of noncompliance with the DHHS Final Rule and the NIH Policy?

1.DHHS Final Rule:  Responsible parties, including, grantee institutions, could be held accountable fornoncompliance, with the potential for substantial civil monetary penalties, the withholding of grant funding from HHS agencies, and criminal proceedings.

2.NIH Policy: Noncompliance with the terms and conditions of the NIH award may provide a basis for enforcement actions.

Pre-existing clinicaltrials.gov records (registered prior to the 2016 final rule and policy)

If you have an existing clinicaltrials.gov record, please be sure to update your record(s), address any errors in your record(s), and submit trial results for studies that are in completed-status.

 

 

For complete guidance on ClinicalTrials.gov registration and clinical trials results submission

1.For School of Medicine clinical trials, contact Mark Bourbonnais (mbourbon@hs.uci.edu) at 949-682-5440.

2.For non-School of Medicine clinical trials, contact Laverne Estanol (lestanol@uci.edu) at 949-824-4704.

3.You can also review the registration and results submission guidance and key resources at:  https://www.research.uci.edu/compliance/human-research-protections/researchers/guidelines-for-registering-in-a-clinicaltrialsgov-registry.html

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Human Research Protections

 

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