Best Practices For Participant Safety: Assessment, Documentation & Reporting Of Adverse Events

Identifying and monitoring adverse events (AEs) is critical to protecting research participants and ensuring the integrity of the research trial. This whitepaper examines key aspects in adverse event identification and monitoring, with a specific focus on IND studies, incorporating an unfolding case study after the expedited reporting information is shared. The first section focuses on an overview of AEs, including a quick definition review. The second section discusses adverse event assessment, focusing on AE terminology, severity rating scales, and attribution assessment. The third section examines AE collection documentation. The fourth and final section discusses expedited reporting of adverse events to both the sponsor as well as to the IRB.