ClinicalTrials.gov

ClinicalTrials.gov was mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and expanded under the Food and Drug Administration Amendments Act of 2007 (FDAAA).  Final regulations will be effective as of January 18, 2017.  All “Applicable Clinical Trials” are required to be registered and have results entered on ClinicalTrials.gov.  For complete statutory definitions and more information about the meaning of "applicable clinical trial," see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF).

Non-compliance with ClinicalTrials.gov registration and results reporting may result in fines up to $10,000 per day. Per Duke Policy, Applicable Clinical Trials will not receive institutional approval until the study has been registered on ClinicalTrials.gov

ClinicalTrials.gov Language in the Consent Form

By federal regulation, ACTs must include the following language in the consent form.  The language cannot be altered in any way.

"A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by US law.  This website will not include information that can identify you.  At most, the website will include a summary of the results.  You can search this website at any time."

Effective January 18, 2017, all NIH-funded interventional clinical trials must be registered and have results submitted in ClinicalTrials.gov. All interventional trials are included in this policy, even those that are not considered to be Applicable Clinical Trials (ACTs), such as behavioral, surgery, phase 1 drug, and feasibility device studies. This policy applies to studies that are funded in part or whole by the NIH, and are submitted on or after the effective date. Registration of NIH-funded studies must be completed before full institutional approval can be received. Results, including adverse events, must be submitted within one year from the date the last patient was evaluated for the primary outcome measure.

NIH definition of clinical trial – one or more human subjects is prospectively assigned to one or more interventions that evaluate the effects of those interventions on health related biomedical or behavioral outcomes.

For further information on the NIH definition of clinical trial, see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

Registration in ClinicalTrials.gov is required for all “Qualifying Trials”, meaning clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1. The National Clinical Trial (NCT) Number that is assigned by ClinicalTrials.gov must be included on all hospital and professional claims for related items/services.  Per Duke Policy, all qualifying trials that are billing to insurance must be registered before the study can receive institutional approval in eIRB.

The International Committee of Medical Journal Editors (ICMJE) requires that all clinical trials be entered into a public registry as a condition of consideration for publication. 

ICMJE defines a clinical trial as “any research that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and–effect relationship between a medical intervention and a heath outcome.”  Medical interventions include drugs, procedures, devices, behavioral treatments, dietary interventions and process-of-care changes.  

Many journals follow ICMJE guidelines.

For each clinical trial supported by a federal department or agency, one IRB-approved consent form must be uploaded to a publicly available federal website after enrollment has closed. To facilitate compliance with this requirement, any federally-supported clinical trial with initial IRB approval on or after January 21, 2019 will need to be registered on ClinicalTrials.gov before receiving full institutional approval in OnCore. After enrollment has closed, one IRB-approved consent form will need to be posted in the ClinicalTrials.gov record. This consent form can be posted by the study team in ClinicalTrials.gov at the same time they are making status updates and editing completion dates. Please contact DOCR-ctgov@duke.edu for questions or assistance.