Course Description

ISO 14155:2020 - Responsibilities of Principal Investigator

Course Description:

This course details the principal investigator’s qualification requirements and responsibilities throughout all stages of clinical investigations. 

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Recognize the responsibilities and specific requirements of the principal investigator
  • Understand that the investigator must have qualified, duly trained team members involved in all aspects of clinical investigations  
  • Be aware that if the principal investigator delegates tasks to authorized designees, they must be recorded in the investigation personnel log
  • Understand all other investigator’s responsibilities

Who Should Enroll:

Clinical research associates (monitors), clinical study coordinators, assistant senior clinical research associates, clinical project and data managers, data entry personnel, ethics committee and institutional review board members, regulators, and notified body personnel involved in auditing clinical evaluations are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • A basic understanding of clinical investigations
  • ISO 14155 - Scope (IDN158)
  • ISO 14155 - Ethical Considerations (IDN175)
  • ISO 14155 - Clinical Investigation Planning (IDN176)
  • ISO 14155 - Clinical Investigation Conduct (IDN177)
  • ISO 14155 - Clinical Investigation Close Out (IDN178)  
  • ISO 14155 - Responsibilities of Sponsor (IDN184)

Subject Matter Expert:
Danielle Giroud

35 min

Related resources:

Case studies:

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