Products
-
Unanticipated Problems
CourseUnanticipated Problems are more than adverse events. Learn how U.S. regulations define UPs, how they differ from routine AEs, and how to recognize when new information triggers IRB reporting and participant protection obligations.
$5
-
Safety Reporting- Understanding Site Reporting Requirements- Drugs and Devices
CourseAdverse event reporting doesn’t stop at recognition. This focused session walks through PI and site reporting responsibilities under U.S. regulations—clarifying what to report, when to report it, and how to document decisions with confidence.
$10
-
Safety Reporting- Site Responsibilities and Documentation- Drugs and Devices
CourseA clear, site-focused walkthrough of Principal Investigator safety responsibilities in U.S. clinical trials—covering adverse event oversight and regulatory expectations that protect participants and keep studies inspection-ready.
$10
-
Understanding Adverse Events and Adverse Device Effects
CourseA clear, practical introduction to adverse event definitions across FDA, ICH, and ISO—designed to help sites recognize AEs confidently in drug and device clinical trials.
$10