Training Program Title
ICH GCP E6 (R2): From the site’s perspective
CTSA Hub Administered
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Training Program Description
The International Council for Harmonisation (ICH) published a revision to GCP E6 based on feedback from the global clinical research community, advancements in technology and risk management developments. ICH states that the goal of the changes is to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct oversight, recording, and reporting while continuing to insure human subject protection and data integrity”. This presentation will address the amendments and additions to the investigator responsibilities at a research site as well as best practices to meet those requirements.
This is a 30 minute internet media player video of a voice over slide show.
A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.
Responsible conduct of research, Best practice, Research study management, Data management
Digital Commons Disciplines
Cost to Access
Scientific Concepts and Research Design; Clinical Trials Operations; Study and Site Management; Data Management and Informatics
- Describe the ICH GCP E6 (R2) changes for Investigator Responsibilities at a research site
- Understand the rationale for changing the fundamentals of the monitoring process
- Recognize how the (R2) Risk Base Monitoring will affect the Site
Clinical Research Professionals (other than PI)