Investigators should be aware that studies that meet the definition of clinical trial may be subject to additional regulatory and/or policy requirements, such as posting of consent forms on federal ...

Why do clinical trials need to be registered at ClinicalTrials.gov? Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires registration of all clinical trials and ...

Learn more about the FDA definition of an "applicable clinical trial." The site uses a web-based data entry system called the Protocol Registration and Results System (PRS) to register clinical ...

With mandatory clinical trial registration now in place for most novel therapeutic interventions, key questions remain on how to maximize the potential benefits of the enhanced transparency that ...