INTERACTIVE DEMO AVAILABLE BELOW

ICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.

This interactive eLearning course covers the importance of ICH and why a revision to E8 was needed, overarching themes of changes, the introduction of Quality by Design and Critical to Quality applied to clinical trials, an overview of the sections of the Guideline, and scenarios.

Course Length: 45 minutes plus additional time for activities

INCLUDES:

• Unlimited access to the content for 45 days from your initial day of purchase.

• Certificate of completion

• Case Studies

• Post-Assessment

• Knowledge Checks

LEARNING OBJECTIVES

1. Recognize how ICH E8(R1), the Guideline for General Considerations for Clinical Studies, has changed organizational processes.

2. Apply the Guideline to key concepts in clinical trials.

3. Discuss implementation challenges and opportunities regarding the updates in the Guideline.

AUDIENCE

A foundation training applicable for all clinical research professionals involved with the design, planning, and conduct of clinical trials.

INTERACTIVE DEMO: