An individual case safety report of one or more adverse events that must be submitted within a specified amount of time due to the severity

Adverse drug reaction reporting / safety reporting from clinical trials is a key component for drug regulatory authorities to take decision as whether to approve

The U.S. National Institutes of Health (NIH) defines a clinical trial as: “A research study, in which one or more human subjects are prospectively assigned

Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, all medicinal products, medical devices and vaccines may also