This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155" which is available at:
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Read more about good clinical practice (GCP) here:
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Chapters:
00:00 Introduction
00:17 About the instructor
00:48 GCP quality standard
01:30 Required documentation
02:25 ICH
03:36 ISO 14155
05:13 ISO 14155 requirements
06:08 Additional resources

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