ICH E8

ICH E8 Section 5 – Design Elements and Data Sources for Clinical Studies

This course explores many key characteristics of well-designed clinical trials. By examining the elements outlined in ICH E8 Section 5, you’ll gain important insights into creating clear, manageable, and successful studies, including recruitment, study population, control groups, data collection, and techniques for minimizing bias.

CEU Credits: 0.1
Course Code: ELM-940
Duration: 10 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 05/20/2024

Curriculum for this course

ICH E8: Section 5: Study Designs and Data Sources
Designing a Clinical Trial: Keeping it Simple
Choosing the Right Participant
The Ideal Participant
Diversity in Clinical Trials
Why Do Studies Use Control Groups
Choosing the Right Control Group
Treatment Description
Participant Puzzle
Response Variables
Study Data Questions
Methods to Reduce Bias
Number Crunching
Following the Road Map
Test your Knowledge!
v1.0 - Course Released on 11/26/2024

Author

Nick Cohen

GxP Quality Assurance Expert

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