Sep 20, 2021 8:45 AM

A team of seasoned clinical research professionals along with OCR Compliance and ACC DOCM collaborated to create a PSOM Guidance for Adverse Event Assessment, one that aligns with clinical workflows. The intent of the guidance is to provide early, mid and senior career investigators a roadmap for how to investigate, perform, and confirm AE assessments.  The guidance will be posted on the OCR website www.med.upenn.edu/ocr/faq.html under Adverse Events.