Course Description

Introduction to Good Clinical Practice

Course Description:

This introductory course explores the fundamental elements and objectives of Good Clinical Practice (GCP) and illustrates why and how it is enforced throughout clinical investigations.

This course also introduces the major requirements outlined in the Declaration of Helsinki and the applicable documents that cover medical device GCP in accordance with ISO 14155, 21 CFR Parts 812, 50, and 56, and the Japanese ICH for medical devices.

Learning Objectives:

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

  • Define the basic elements and objectives that compose GCP
  • Comprehend, in detail, the requirements outlined in the Declaration of Helsinki
  • Understand which rules and regulations stipulate GCP requirements worldwide

Who Should Enroll:

Monitors, clinical research associates and investigators, study coordinators, and quality assurance, regulatory, sales, and marketing professionals wanting to understand the basic requirements of GCP are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following course is recommended:

  • History of Good Clinical Practice (GCP) (ID 41)

Subject Matter Expert:
Danielle Giroud

45 min

Related resources:

Case studies:

Basic Account: € 109.00
Premium Account: € 82.00

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