GCP ICH

 TRAINING PROGRAM

COURSE ID GCR0021 GCP: ICH-GCP Good Clinical Practice for professionals

Learning objectives

• Explain why and how the ICH influences clinical research practice through its guideline on GCP, and summarise the principles of GCP.

• Identify the major roles in a clinical trial team, outline the responsibilities of each, and discuss how they work together.

• Describe the responsibilities of a trial sponsor. Describe the responsibilities of a clinical investigator.

• Explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.

• Describe the responsibilities of a trial monitor.

Target audience

• Clinical research associates, 

• Project managers 

• Employees of companies sponsoring clinical research,

• All healthcare professionals involved in conducting clinical trials. 

Overview

• ICH, harmonization, and principles of GCP 

• Clinical research teamwork 

• Documentation 

• Sponsor responsibilities 

• Investigator responsibilities 

• Informed consent 

• Clinical trial monitor responsibilities