Course Description

Applying GDPR to Medical Devices Clinical Investigations

Course Description:

Untangle the mysteries about GDPR for medical device clinical investigations. The course provides a detailed review of the GDPR requirements and how these apply to medical device investigations. The different parties involved i.e. controllers, processors and data protection officers and their responsibilities are described. The course provides a comprehensive outline of how companies should apply privacy by design including the process of a data protection impact assessment.

Learning Objectives:

Upon successful completion of this course, learners will understand and apply

  • the basic terminology around GDPR
  • the different roles and responsibilities of controllers, processors and data protection officers.
  • what is meant by privacy by design and related principles 
  • the rights of data subjects
  • required reporting of data breaches.
  • how to implement privacy by design by using different principles including the data protection impact assessment (DPIA).

This course includes examples of contents of a DPIA.

Who Should Enroll:

Clinical research associate (monitors), clinical study coordinators, clinical trial assistants, clinical project and compliance managers, clinical quality managers and associates, clinical investigators, clinical affairs directors, regulatory managers

Prerequisite Knowledge/Requirements:

No pre-requisite knowledge is required.

Subject Matter Expert:
Danielle Giroud

37 min

Related resources:

Case studies:

Basic Account: € 124.00
Premium Account: € 94.00

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