Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles
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This lesson is part of a complete GCP track — 2 courses, quizzes, a final exam, and a free verifiable credential. The optional $29 PDF certificate is recognized by 18+ trial sponsors.
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Master the practical procedures for IRB/IEC submissions, amendments, continuing review, and safety communication that ensure uninterrupted ethical oversight.
Knowing that an IRB/IEC must review and approve a clinical trial before it begins is foundational. But what does that actually look like when you are the coordinator preparing the submission package at 4:30 on a Friday afternoon, hoping to make the next committee meeting? What happens when new safety information emerges mid-trial and the protocol needs urgent modification? How do you track the anniversary of your approval date when you are managing twelve active studies simultaneously?
This lesson bridges the gap between the principled requirements you learned in Lesson 1 and the practical execution that occupies much of a site team's daily work. The requirements in ICH E6(R3) Annex 1, Sections 1.2 and 1.4, translate into specific procedures: what goes into a submission package, how amendments move through the system, what triggers expedited versus full board review, and how safety information reaches the committee that needs to evaluate it.
I have found, over many years of observing sites, that the difference between struggling and thriving research programs often comes down to their IRB/IEC operations. Sites that master these processes run trials smoothly. Sites that treat IRB submissions as afterthoughts find themselves with enrollment holds, protocol deviations, and strained relationships with their ethics committee.
What you will learn5 objectives
By the end of this lesson, you will be able to:
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