Training Program Title

ICH GCP E6 (R2): From the site’s perspective

CTSA Hub Administered

no

Contact Information

Contact us by emailing office@socra.org or calling 215-822-8644.

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.

Competency Keywords

Responsible conduct of research, Best practice, Research study management, Data management

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

yes

Competency Domains

Scientific Concepts and Research Design; Clinical Trials Operations; Study and Site Management; Data Management and Informatics

Learning Objectives

  • 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

Delivery Method

Online

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Skilled

Onboarding

no

Frequency

On demand

Time Needed

30 minutes

Associated Assessment

yes

Assessment Methods

Learning outcomes

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