Which studies require registration?

The University of Miami requires registration on ClinicalTrials.gov for all Clinical Trials (as defined by NIH), and for all Clinical Studies/Registries with Medicare billing implications, prior to enrollment of the first participant. This is applicable to studies where the University of Miami Principal Investigator has initiated, sponsored or been designated the Responsible Party for registering such Clinical Trials. See Policy HSR-P-101

Below is a figure that depicts the regulations and requirements included in the University of Miami Policy on Clinical Trial Registration (HSR-P-101).