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ClinicalTrials.gov Registration and Reporting

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and internationally. It provides patients, family members, health care professionals and members of the public access to information about clinical trials for a wide range of diseases and conditions. Registration in the ClinicalTrials.gov registry works 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.

ClinicalTrials.gov was developed by the National Institutes of Health (NIH), through its National Library of Medicine (NLM). The registry is a collaborative effort between the NIH NLM and the Food and Drug Administration (FDA), and is a result of the 1997 FDA Modernization Act. In September 2007, a US law (Public Law 110-85, Title VIII, also called the FDA Amendments Act of 2007, or FDAAA) expanded the types of clinical trials that must be registered in Clinicaltrials.gov, increased the number of data elements that must be submitted, and also required submission of results data for certain applicable clinical trials. The NIH encourages registration of all clinical trials, whether required under the law or not.

The first step to registering a trial on ClinicalTrials.gov is to secure a Protocol Registration System (PRS) account.  This account allows investigators to create and update clinical trial records as necessary. For more information visit the clinicaltrials.gov website at: http://clinicaltrials.gov/ct2/manage-recs/how-apply, or contact register@clinicaltrials.gov.

NIH Information on the Policies, Roles and Responsibilities regarding ClinicalTrials.gov:

Additional Information about ClinicalTrials.gov:

Last updated October 8, 2014