Adverse Events and Serious Adverse Event Management

These adverse events are already known as potential risks when participating in a research study with a specific investigational product. At the time a participant begins a research study, it is important to have a documented baseline assessment that is detailed with 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.

Research studies involving interventions such as drugs, biologics or devices require the investigators and sponsors to appropriately report any serious adverse events (SAEs) observed in human participants that are considered serious, unexpected and related to the investigational product as defined by federal regulations. These unanticipated problems need to be reported promptly to the IRB, sponsor and federal agency because they may involve greater risks to human subjects or others than previously expected. Each entity has defined reporting requirements for serious adverse events. It is important to note that sometimes the event is required to be reported to the sponsor as an SAE but it may not need to be reported to the IRB. The research team must be familiar with the various reporting definitions, requirements, and timelines that the reports must be completed. It is important to document when the research team is informed of a potential SAE. This is the point when the timeline for submitting the required reports begins. Sometimes only minimal information is known at the time the initial reports are due; additional information can be submitted once it is available as an amendment to the initial report.

Most reports require a brief history of the event. This description should be professionally written and presented factually. Key information that is helpful to the reviewers of the reports are: participant demographic information, when the participant started the research study, what research intervention the participant was receiving, previous medical history, concomitant medications, last exposure to investigational product, abnormal labs or diagnostic tests, when the study team was notified of the event, description of the actual event, relationship of the AE to the investigational product, whether the participant was hospitalized, if the event has resolved or not, and whether the participant will be removed from the research study or continue to receive the research product.

• HRPP Policy on Event Reporting 
• IRB Event Reporting Form
• FDA Medwatch Form 3500 
• WIRB Forms 
• FDA: 21 CFR 312.32 IND Safety Reports 
• FDA: Reporting Adverse Events (Medical Devices)