ClinicalTrials.gov is a consumer-friendly database with information on clinical studies funded and/or sponsored by the NIH, other federal agencies, and private industry. The database was developed by NIH, through its National Library of Medicine (NLM), in collaboration with the Food and Drug Administration (FDA).

The Food and Drug Administration Amendments Act of 2007 (also called FDAAA) requires that clinical trial sponsors register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulation (see Public Law 110-85, Title VIII).  Penalties for failure to register a trial with complete information may include civil monetary penalties and the withholding of federal grant funds.

Find more information on requirements and developing information concerning FDAAA. Clinical trial sponsors are required to register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulations.

Register Your Clinical Trial

Sponsors can register clinical studies on clinicaltrials.gov via a web-based data entry system called the Protocol Registration and Results System (PRS). To register your clinical trial:

1. Check to see whether your organization already has a PRS organization account.
2. Apply for a PRS account. See how to apply for an account on ClinicalTrials.gov.
3. Logon to PRS on the PRS Login Page.
4. Enter the required and optional data elements.
5. Preview, inspect, and submit the record.

Contact your organization's Clinicaltrials.gov account administrator to register your trial. If you do not know your account administrator, contact register@clinicaltrials.gov for assistance.

Update Trial Information

You are responsible for maintaining the accuracy of the trial information in ClinicalTrials.gov and for reporting results. To update your trial information:

1. Logon to Clinicaltrials.gov.
2. Select MODIFY.
3. Select EDIT next to your trial's listing.
4. Select EDIT next to the block of information you wish to edit.
5. Select OK at the bottom of the page when your editing is complete.
6. Select RESET TO COMPLETED near the top of the page.
7. Select APPROVE.
8. Select RELEASE.

Report Results

You are required to submit results of data. It is important to note that results-reporting requires a fairly sophisticated knowledge of the study. To report your trial results:

1. Logon to ClinicalTrials.gov.
2. Select MODIFY.
3. Select EDIT next to your trial's listing.
4. Scroll down to “For Completed Studies” and select ENTER RESULTS.
5. Begin entering results.

Helpful Links and Resources

• Clinicaltrials.gov Assistance: register@clinicaltrials.gov.
• Logon Clinicaltrials.gov.
• International Committee of Medical Journal Editors requirements: International Committee of Medical Journal Editors requirement.
• Public Law Information: FDAAA (Public Law 110-85) information.
• FAQs: Clinicaltrials.gov.

More on the FDAAA

Under the 1997 FDA Modernization Act, NIH was instructed to establish a database of therapeutic clinical trials that is understandable and accessible to the public. The purpose of this legislation was to make information about clinical trials available to members of the public who are suffering from diseases so they can apply to be research subjects.

ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

The Food and Drug Administration Amendments Act of 2007 (also called FDAAA) was passed on September 27, 2007. The law now requires that the “Responsible Party” must register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulation (see Public Law 110-85, Title VIII). It also mandates that some previously optional data elements are now required. In general, the Responsible Party is defined as the sponsor of an applicable clinical trial. The law also allows the role of Responsible Party to be assigned to the Principal Investigator (PI) if the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA’s requirements for the submission of clinical trial information. For investigator-initiated clinical trials, NIH is generally not the sponsor and, as such, NIH would not be the Responsible Party. Under this law, the Responsible Party is accountable for compliance, including accuracy and completeness of the data. Penalties for failure to register a trial with complete information may include civil monetary penalties and the withholding of federal grant funds.

ClinicalTrials.gov also helps to register trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.