Best Practices for Participant Safety: Assessment, Documentation and Reporting of Adverse Events

A Complion Whitepaper

Identifying and monitoring adverse events (AEs) is critical to protecting research participants and ensuring the integrity of the research trial.

"Best Practices for Participant Safety: Assessment, Documentation and Reporting of Adverse Events," draws on the considerable experience of Elizabeth Ness (MS, BSN, RN), Ilana Logvinov (RN, MSN, CCRP), and Yolanda McKinney (RN, BSN, CCRP) to help you gain a better understanding of key aspects of adverse event identification and monitoring.

The whitepaper provides readers with:
 

  • An overview of AEs, including a quick definition review.
  • A discussion of adverse event assessment, focusing on AE terminology, severity rating scales, and attribution assessment.
  • An examination of AE collection documentation.
  • A discussion of expedited reporting of adverse events to the sponsor and the IRB.


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