1/06/2020

What is ICH E3 and why is it important?

ICH E3 is one of the ICH technical Guidelines related to clinical trials to promote harmonization globally. The purpose of the Guidance is to harmonize clinical study reports (CSR) across all regulatory authorities. ICH E3 provides guidance for the sponsor for what needs to be included in the CSR and to develop a CSR that is complete, specific, well-organized, and easy for those receiving the CSR to review.

How does the eLearning support sponsors and those that support the development and updates to a CSR? The Clinical Pathways’ Clinical Study Report interactive eLearning includes:

a review of ICH
an overview of the CSR
the body of the clinical study report
review of the 2012 ICH E3: Structure and Content of Clinical Study Reports Questions and Answers document
conclusions and other topics related to the challenges of CSRs

Understanding what is important to include in a clinical study report can proactively support efforts to follow GCP.

The eLearning course offers:

Interactive content
Knowledge Checks
Scenarios to apply your knowledge
Post Assessment
Certificate of Completion

To sample an interactive demo or to purchase the full course, visit our store here. Contact us for information about training your team.

- The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.