The recently enacted U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007, FDAAA), Title VIII, Section 801 mandates the expansion of the clinical trials data bank (ClinicalTrials.gov). The new provisions require additional information to be submitted to the databank by the sponsor. This includes expanded information on clinical trials and information on the results of clinical trials.

Based on the timeframes under which the new FDAAA submission requirements take effect, the certifications must be submitted to FDA beginning no later than December 26, 2007. The official certification form, Form FDA 3674 entitled "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank, is now available on FDA's Web site: http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3674.pdf

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.

Additional information for individuals or organizations registering clinical trials in the ClinicalTrials.gov data bank is available on the National Library of Medicine (NLM) Protocol Registration System (PRS) website.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)