Introduction to collecting and reporting adverse events

This introductory online adverse events course is organised as a single, self contained course hosted within the Global Health Training Centre, with clearly stated learning objectives and a structured contents list that users can follow in sequence. Sections such as “Why Adverse Events Should be Recorded”, “What Should be Recorded” and “Types of Adverse Event” guide learners’ step by step through the adverse event reporting process. Users can scroll through the material in order or navigate directly to specific sections of interest, such as detecting adverse events or adverse event follow up.

The course defines adverse events as undesirable or harmful effects linked to the research and shows why systematic documentation of these events is essential for participant safety and trial integrity. It follows the full adverse event pathway from initial identification through to reporting. It explains why adverse events should be recorded, what should be captured in the case report form, and how different types of events are defined. 

The core material consists of concise guidance text supported by examples and questions that underline good practice in adverse event documentation and reporting. It draws on guidance from international organisations, including the World Health Organization, the International Council for Harmonisation and the Council for International Organizations of Medical Sciences, to emphasise that adverse events should be carefully and systematically recorded. The resource also points to the importance of clear protocol guidance on what constitutes an adverse event, what actions should be taken, and how events should be monitored, documented and reported. To access the course materials, users have to register on the Global Health Training Center website.