Register in ClinicalTrials.gov
The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. For more information about this law and requirements for sponsors and/or investigators, visit the Protocol Registration System (PRS) and U.S. Public Law 110-85 Information Page.
Information for Investigators
Organizations or clinical investigators with primary responsibility for initiating and conducting clinical trials may submit trial data to ClinicalTrials.gov using the PRS. A trial must be approved by a human subject review board and must conform to the regulations of the appropriate national health authorities in order to be registered.
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.
- Information on submitting studies to ClinicalTrials.gov