ISO 14155: 2011 – A Summary Review
This course provides a condensed yet inclusive summary review of the ISO 14155 2011 standard.
It covers the following topics:
- When to apply ISO 14155 requirements
- The basics of ethics requirements
- Essential tasks and elements needed during the preparation, conduct, and closing of clinical investigations
- Brief explanation of the main responsibilities of sponsors and investigators
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Upon successfully completing this course, learners will be able to:
- Understand the general requirements of ISO 14155 as a good clinical practice guidance (specifically for medical device clinical investigations)
- Apply ISO 14155 requirements to ethics committee or institutional review board processes internationally
- Identify the requirements of the informed consent process
- Determine the planning needed before, during, and at the termination of a clinical investigation
- Grasp the general the responsibilities of sponsors and investigators
Clinical and quality assurance professionals involved in clinical data and regulatory professionals involved in clinical investigations for medical devices are all welcome to enroll in this course.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.