Is an observational study that is collecting data on patients who may or may not have taken an investigational product considered to be a clinical trial? The sponsor I am working with claims this would qualify as a clinical trial but I don’t agree. Please advise.?
Observational studies are not currently required to be registered/reported on ClinicalTrials.gov by FDAAA. The ICMJE may have a different opinion because subjects are receiving interventions.
