Clinical Trial Sponsor's ICH E6(R3) GCP Responsibilities for Monitoring (CT03G)

Course Summary

A clinical trial monitor acts on behalf of the sponsor to support investigational site personnel, verify the accuracy of data recorded, and ensure that the trial is conducted in compliance with the protocol, GCP and other study specific requirements. He or she acts as the ‘eyes and ears’ of the sponsor at the investigational site and provides the main channel of communication between sponsor and investigator. This short course explores the responsibilities of the monitor and provides insight into key challenges. We discuss assessment of investigators and investigational sites, education and trial initiation, monitoring of clinical conduct, including CRF review and source document verification, and trial close-out. We discuss noncompliance and how to deal with it.

Who will benefit from this module?

This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.

Learning Objectives

• Specify the purpose of monitoring clinical research
• Outline major functions of a monitor before, during and after clinical conduct of a trial
• Discuss issues related to investigator site assessment
• Describe the process of CRF review and discuss issues arising
• Describe the process of source document verification and discuss issues arising
• Specify objectives of monitoring investigational product management
• Discuss types of noncompliance and how to deal with them
• Outline the contents of site visit reports

Module Outline

Key topics covered in this module include:

• The monitor's role
• Monitoring activities
• Investigator site assessment
• Education and trial initiation
• CRF review
• Source document verification
• Investigational product management
• Ensuring compliance
• Reports
• Trial close-out

Assessment - Multiple-choice assessment.