ClinicalTrials.gov is a registry and results database with over 225,000 studies. It 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). In 2016, FDAAA 801 described further registration and results requirements. The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11.4) expands and clarifies FDAAA 801 and went into effect January 18, 2017.
All “Applicable Clinical Trials” (ACT) are required to be registered within 21 days of enrolling the first participant (FDAAA/Final Rule). Results must be entered on ClinicalTrials.gov within 12 months of the Primary Completion Date.
|FDAAA & Final Rule||NIH-funded||ICMJE|
|Why Register?||Federal Law per FDAAA 801 and the Final Rule||Expected for all NIH-funded trials even if not subject to FDAAA 801||Required by most medical journals|
|Applicable Clinical Trial? (ACT)||ACT Checklist||NIH Clinical Trial Definition||ICMJE Clinical Trial Defintion (Updated Dec. 2018)|
|Enforcement||Criminal proceedings and civil/monetary penalties |
Loss of HHS funding
|Witholding/loss of NIH funding||Refusal to publish|
Complete the “Request a Consultation” form at the bottom of this page. Click CTSI Clinical Trials Office and select ClinicalTrials.gov Registration/Consultation from the list of CTO services. Add any specific information in the (Optional) Please provide additional details or specifics for your project section type.
Visit ClinicalTrials.gov How to Register Your Study for a step-by-step explanation of the registration process.
Data Elements Definitions provides a detailed explanation of the data fields within ClinicalTrials.gov. It is highly recommended you use the unique IRB number as the Unique Protocol ID in the PRS data element.
When registering a study, it will have to be decided who is the Responsible Party and the Record Owner. They may be one in the same. By definition:
Responsible Party: An entity or individual who is responsible for registering a clinical investigation and submitting clinical trial information
– Can be the Sponsor for the trial
– Can be the PI if they conduct the trial, control the data and have the rights to publish
Record Owner: The primary contact for the record. Anyone can be the owner of a study. Owners are often Study Coordinators or other study team members and assist the Responsible Party (RP) with data entry. They can be assigned to create the study record, grant other users access and receive e-mail communications along with the RP.
The Responsible Party must update and correct clinical trial information on ClinicalTrials.gov:
The final revisions to the Common Rule related to posting the Informed Consent were effective January 21, 2019:
Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA; [2016 Oct 4;316(13):1353-1354 [Full Text]
Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov – the final rule. N Engl J Med; 2016 Sept 16. [Full Text]
Zarin DA, Tse T, Ross JS. Trial-results reporting and academic medical centers. N Engl J Med. 2015 Jun 11;372(24):2371-2. [Full Text]