Course Description

ISO 14155:2019 – A Summary Review

Course Description:

This course provides a condensed yet inclusive summary review of the latest version of the ISO 14155  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

Watch the Course Trailer:

 

 


Learning Objectives:

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

Who Should Enroll:

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.


Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.


Subject Matter Expert:
Danielle Giroud

Duration:
80 min

Release date:
06/12/2019

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 244.00
Premium Account: € 183.00

Last update - 06/12/2019:
UP to date

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