This web site was copied prior to January 20, 2005. It is now a Federal record managed by the National Archives and Records Administration. External links, forms, and search boxes may not function within this collection. Learn more.   [hide]
Skip to Content
United States National Library of Medicine National Institutes of Health

Fact Sheet

What is provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with all NIH Institutes and the Food and Drug Administration (FDA).

How do I find is available on the World Wide Web from the NLM Home Page ( or directly at (

What information is in

Abstracts of Clinical Study Protocols that include the following information:
• summary of the purpose of the study
• recruiting status
• criteria for patient participation
• location of the trial and specific contact information
Additional Information that may help a patient decide whether to consider a particular trial:
• research study design
• phase of the trial
• disease or condition and drug or therapy under study
Links to Online Health Resources that help place clinical trials in the context of patients' overall medical care, including MEDLINEplus and PubMed.

Why has the National Institutes of Health (NIH) established
The information resource was initiated as a result of the Food and Drug Administration Modernization Act of November 1997. The legislation requires the Department of Health and Human Services, through the NIH, to establish a registry of clinical trials for both federally and privately funded trials "of experimental treatments for serious or life-threatening diseases or conditions."

How are study protocols submitted to
The FDA Guidance Document (March 2002) ( describes the submission criteria. The NLM has developed the Protocol Registration System (PRS), a Web-based tool for submitting information to Study sponsors or their representatives may register online to apply for a PRS account ( facts
• Completely confidential. No registration or personal identification is required.
• Includes thousands of trials sponsored primarily by NIH, other Federal agencies, and the pharmaceutical industry.
• Released February 29, 2000.

Need more information?
NLM's toll-free number is 1-888-FINDNLM (1-888-346-3656) 
NLM's e-mail address is

A complete list of NLM Fact Sheets is available at:
(alphabetical list)
(subject list):

Or write to:

Office of Communications and Public Liaison
National Library of Medicine 
8600 Rockville Pike
Bethesda, Maryland 20894 

Phone: (301) 496-6308
Fax: (301) 496-4450

Last updated: 26 March 2003
First published: 26 March 2003
Metadata| Permanence level: Permanent: Stable Content