Required Registration to ClinicalTrials.gov

ClinicalTrials.gov is a consumer-friendly database with information on more than 13,500 clinical studies sponsored by the National Institutes of Health (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). Studies listed in the database are conducted in all 50 states and in more than 100 countries. Clinicaltrials.gov receives more than 4 million page views per month and hosts approximately 17,000 visitors a day.

On September 27, 2007, a US law (Public Law 110-85, Title VIII) was enacted that expands the types of clinical trials that must be registered in Clinicaltrials.gov, increases the number of data elements that must be submitted, and also requires submission of results data. This law mandates that some previously optional data elements are now required. One of those elements is identifying a Responsible Party for each trial. In general, the law defines the Responsible Party 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 conducting the trial and has sufficient data rights in accord with the law. For grants, NIH is generally not the sponsor and, as such, NIH would not be the Responsible Party. Under the new law the Responsible Party will be held accountable for compliance. Penalties for failure to register a trial with complete information are significant and may include civil monetary penalties and, the withholding of federal grant funds.

NINDS remains committed to advise and guide our investigators on how to comply with the new law, because under the new law the PI and/or Responsible Party now is responsible for the accuracy and completeness of the data. 

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.

Clinical studies are registered on clinicaltrials.gov via a web-based data entry system called the Protocol Registration System (PRS). NLM assigns each NIH institute a PRS account under which the trials the institute sponsors may be registered. The PIs home institution also may have a PRS account under which trials can be registered. PRS accounts are managed by administrators. PRS Account Administrators are available to help setup individual accounts in the clinicaltrials.gov database.

How to Register

The first step to registering your trial on ClinicalTrials.gov is to secure a PRS account. The NINDS ClinicalTrials.gov Administrator, Ms. Shannon Garnett, can assist you in setting up your account. Please send her the name and email address of the person from your trial/study who will be responsible for registering and/or managing future updates including reporting trial/study results. Please contact her at: sg71v@nih.gov or 301-496-5751. It is important to note that results-reporting requires a fairly sophisticated knowledge of the study. We will be happy to arrange assistance for registration and/or posting updates if requested. 

Updating Trial Information

Under the new law, the PI, Responsible Party, and/or the account designee is responsible for maintaining the accuracy of the trial information in ClinicalTrials.gov and for reporting results. The complete and accurate ClinicalTrials.gov record will fulfill both the International Committee of Medical Journal Editors and Federal registration and results reporting requirements, including those newly mandated under Public Law 110-85. More information about Public Law 110-85 is available at the following link: http://prsinfo.clinicaltrials.gov/fdaaa.html.

Background

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. The database (and its companion public web site) was created and is maintained by NLM. See www.clinicaltrials.gov.

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.

For additional information, see:

• Information on U.S. Public Law 110-85
• FAQs — Clinical Trials Registration in ClinicalTrials.gov
• ClinicalTrials.gov Fact Sheet
• NIH Guide Notice: Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration
• Clinical Trial.gov Data Element Definitions
• Basic Results Data Element Definitions
• Registering with ClinicalTrials.gov Brochure