RRT 130: ICH Good Clinical Practice (GCP) Training

Content
1 module

Rating

Course length
30 mins

Instructor
Miranda Schramm

Description

Content reflects ICH GCP E6 (R3)

The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. 

GCP training aims to ensure that:

  • the rights, safety, and well-being of human subjects are protected
  • clinical trials are conducted in accordance with approved plans with rigor and integrity
  • data derived from clinical trials are reliable

View each video to learn more about different topics in GCP.  To pass this course, you must complete the assessment with a score of 80% or greater. 

 

Objectives

  • What is GCP? 
  • Core Principles
  • Sponsor's Role and Responsibilities
  • Investigator's Role and Responsibilities
  • Informed Consent
  • Safety Reporting
  • Investigational Product Management
  • Essential Documents

Certificate

By completing/passing this course, you will attain the certificate Advarra ICH GCP Completion Certificate

1.
RRT 130 ICH Good Clinical Practice (GCP) - GCP E6 R3
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