Endocrine Insider
November 21, 2007

The Protocol Registration System (PRS) of ClinicalTrials.gov has information online regarding new registration and reporting requirements. The information is intended to help those who conduct clinical trials to navigate the requirements set forth in the Food and Drug Administration Amendments Act of 2007, which was signed into law by the president earlier this year (U.S. Public Law 110-85).

The Web page http://prsinfo.clinicaltrials.gov/fdaaa.html includes instructions to investigators who are currently registered with PRS and those who anticipate needing to register, as well as links to:

• Required data elements—high level list of the required elements and requirement status relative to previous law
• New requirements for interventional clinical trail registration—a detailed description of the data elements
• NIH fact sheet—description of general requirements, timing of registration, and penalties for failure to register
• Guidance document from the NIH Office of Extramural Research—detailed analysis of the new law (including links to the text of the law) and instructions for obtaining help from NIH