Introduction to Collecting & Reporting Adverse Events
Adverse Events can be defined as undesirable or harmful effects or experiences arising or linked to the clinical research being carried out. This short course provides a general introduction and overview of Adverse Events and how to deal with them when they occur. This course is suitable for everyone involved in clinical research.
Upon completion of this course, you will have an understanding of:
- The importance of collecting, recording and reporting adverse events;
- The definition for the different categories of adverse events;
- The mechanisms used for identifying these events, how they are evaluated when they occur and how follow-up may be carried out;
- The necessity of assessing a causal relationship between the study intervention and the adverse event; and
- What data is typically reported and who receives the reports.
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