Investigator Instructions

Organizations or clinical investigators with primary responsibility for initiating and conducting clinical trials may submit trial data to using the Protocol Registration System (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.

For more information visit the PRS Information Page (

Investigators or sponsors for trials which have been registered with by another individual or organization should contact that data provider directly with any questions or concerns regarding the information posted on

U.S. Public Law 110-85 (FDAAA)

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 PRS and U.S. Public Law 110-85 Information Page.