ICH E8

ICH E8 Section 7 – Considerations in Identifying Critical to Quality Factors

ICH E8 Section 7 details Critical-To-Quality factors, which are foundational considerations in designing and conducting safe and successful clinical trials.  By exploring the best practices outlined in this course, learners will have an increased understanding of how sponsors, researchers, and participants can work collaboratively to ensure the accuracy, and scientific validity of clinical research.

CEU Credits: 0.1
Course Code: ELM-942
Duration: 20 mins
Skill Level: Basic
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 05/31/2024

Curriculum for this course

Critical- to-Quality Factors
Study Design CtQs
Non-Clinical Trials
Clear Endpoints
Control Groups
Feasibility
Study Population and Endpoints
Inclusion Criteria
Bias
Training
Participant Protection CtQs
Data Management CtQs
CtQ Chat
Monitoring and Reporting CtQs
The Roadmap
Test your Knowledge!
v1.1 Minor update on 3/10/2025 to correct a typo error in the file name.
v1.0 Course released on 02/25/2025