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Module 1: Lesson 1
Principle 9: Reliable results
Learn how ICH E6(R3) establishes the systems, processes, and documentation requirements that ensure trial results are reliable enough to support regulatory decisions and clinical practice.
Principle 9: Reliable results
Every activity in a clinical trial—every consent conversation, every dose administered, every measurement recorded—ultimately serves a single purpose: generating results that can be trusted. If participants cannot trust that their contribution will produce meaningful evidence, why would they volunteer? If regulators cannot trust that the data reflect reality, how can they approve new therapies? If clinicians cannot trust that trial findings apply to their patients, what good is the research?
Principle 9 of ICH E6(R3) addresses this fundamental question: What does it take to produce reliable results?
The answer, it turns out, is not simply "be careful" or "follow procedures." Reliability requires integrated systems that capture information appropriately, protect data integrity throughout its lifecycle, and make results accessible to those who need them. It requires proportionate attention—not equal attention to everything, but focused attention on what matters most. And in an era where trials increasingly involve computerized systems, decentralized elements, and global data flows, reliability requires deliberate design.
This lesson examines Principle 9 and its sub-principles, which together establish the framework for generating trial results that regulators, clinicians, and patients can trust.
What you will learn
By the end of this lesson, you will be able to:
Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles