Recommendations for Adverse Event Collection and Treatment Emergent Definition

In 2019, the PHUSE Best Practices for Data Collection Initiatives project team, in conjunction with the Analysis and Display of Safety Analytics project team, conducted a survey (link) to study the variation in the collection and definition of treatment emergent adverse events (TEAEs) in clinical studies. It noted the need to pursue additional research to further harmonise industry practices. The PHUSE Adverse Event Collection Recommendations and the Treatment Emergent Definitions Recommendations project teams were formed to develop recommendations to reduce the implementation variability.

Adverse Event Collection Recommendations: The PHUSE Adverse Event Collection Recommendations project team developed recommendations for the collection of adverse events which aim to improve the quality of the data and the site experience, as well as provide the data for treatment emergent definitions and for recommended analyses and displays. Earlier this year, the project team issued a white paper (link) documenting the recommendations. This webinar will provide an overview of the white paper, including time for Q&A.

Treatment Emergent Definitions Recommendations : The PHUSE Treatment Emergent Definitions Recommendations project team conducted a survey to solicit input from industry and regulatory respondents on various TEAE scenarios for a simple clinical study design. The project team developed a white paper (link) with recommendations for standardising the TEAE definition based on the survey results, as well as their collective experiences. This webinar will provide an overview of the white paper, including time for Q&A.