Adverse events and Serious adverse events are already known as potential risks when participating in a research study with a specific investigational product. Before a participant begins a research study, it is important to have a documented baseline assessment that is detailed with a health history and current health issues prior to exposure to the investigational product. As the participant is exposed to the investigational product, the research team must document any changes in health that may be due to the research study product and report these adverse events through normal data collection tools provided by the sponsor.
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