Clinical Research Director
6
Resources
148
Total Views
0
Downloads
5.0
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Dr. Sarah Chen has over 15 years of experience in clinical research, specializing in ICH GCP compliance and regulatory affairs.
15+ years of experience
6 resources by Dr. Sarah Chen
Learn the fundamental principles of GCP and why these guidelines are essential for ethical clinical research.
Understand the structure and key changes in ICH E6(R3) and how they impact clinical trial conduct.
Learn the essential elements of protocol development and best practices for managing amendments during trial conduct.
Quick reference for SAE reporting timelines from investigator notification through regulatory submission.
Quick guide to classifying protocol deviations by severity and determining required reporting actions.
Navigate ICH E6(R3) quickly with this section-by-section overview of the updated GCP guideline.
Clinical Research Director
6
Resources
148
Total Views
0
Downloads
5.0
Avg Rating
Dr. Sarah Chen has over 15 years of experience in clinical research, specializing in ICH GCP compliance and regulatory affairs.
15+ years of experience
6 resources by Dr. Sarah Chen
Learn the fundamental principles of GCP and why these guidelines are essential for ethical clinical research.
Understand the structure and key changes in ICH E6(R3) and how they impact clinical trial conduct.
Learn the essential elements of protocol development and best practices for managing amendments during trial conduct.
Quick reference for SAE reporting timelines from investigator notification through regulatory submission.
Quick guide to classifying protocol deviations by severity and determining required reporting actions.
Navigate ICH E6(R3) quickly with this section-by-section overview of the updated GCP guideline.