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Required Registration to ClinicalTrials.gov

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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 and it adds four new required data elements. One of those elements is identifying a Responsible Party for each trial. An NIH Institute cannot be listed as the Responsible Party, in most NIH funded trials the Responsible Party is the principal investigator (PI). 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 available to help its PIs enter the data into Clinicaltrials.gov, but under the new law the PI now becomes responsible for the accuracy and completeness of the data. Similarly the sponsor is defined as the person or organization who initiates the clinical trial. The sponsor is not the NIH unless the NIH holds the IND or IDE. It may be the PI or the institution for which the PI is employed.

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 institute a PRS account in which to maintain the trials the institute sponsors. PRS accounts are managed by administrators from the institutes.

PRS Account Administrators are available to help register trials in the clinicaltrials.gov database. They work with the principal investigators and trial coordinators to ensure that the information is correct, readily understood by the general public, and updated in a timely manner. The Administrators serve as points of contact for the clinicaltrials.gov team and resolve questions associated with the information provided.

How to Register

To register your NINDS-sponsored trial, please provide information to the NINDS PRS Account Administrator. For the list of required items please review the ClinicalTrials.gov Data Element Definitions for Interventional Clinical Trials.

The NINDS PRS Account Administrator is:

Shannon Garnett
NIH-NINDS-OCPL
Building 31, Room 8A-06
31 Center Drive MSC 2540
Bethesda, Maryland 20892-2540
e-mail: sg71v@nih.gov
fax: 301-402-2186

All trials submitted must have approval of a human subjects review board, such as an institutional review board, ethics committee, or equivalent group.

With the information you submit, Ms. Garnett will create a lay-language summary of your trial. The summary must then be reviewed and approved by the trial principal investigator, NINDS program director, and the director of the Office of Communications and Public Liaison, NINDS, before being posted in the clinicaltrials.gov database.

Updating Trial Information

Based on the date a trial is entered in the database, the PRS system automatically alerts the Administrator every 6 months to review and, if necessary, update the trial information. The Administrator will contact the principal investigator and/or the trial coordinator to review and update the information. However, you may contact the Administrator at any time if you wish to update your trial information.

Background

Under the 1997 FDA Modernization Act, the 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. NIH instructed each institute to fulfill the requirements of the law for its trials. The communication offices help to coordinate the content data for the database and to summarize the information in simple, lay language. The database (and its companion public web site) was created and is maintained by the 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:

Last updated December 21, 2007