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Module 1: Lesson 1
When Things Go Wrong: Inspections and Enforcement
Understanding how regulatory agencies verify compliance, what happens during an inspection, and the consequences of violations in clinical research.
What you will learn
By the end of this lesson, you will be able to:
Why inspections happen
Clinical trials operate on trust. Sponsors trust that investigators follow protocols. Regulatory agencies trust that submitted data reflects reality. Participants trust that their safety is protected. But trust alone is insufficient when lives are at stake.
Inspections exist because verification is essential. When the FDA reviews a marketing application, they are deciding whether millions of people should receive a new medication. That decision depends entirely on data from clinical trials. The agency cannot simply take the sponsor's word that the data is accurate. They must verify.
Think of it this way: if you were about to take a new medication, you would want to know that someone independent had checked whether the clinical trials were conducted properly. Did participants actually give informed consent? Were the eligibility criteria followed? Were adverse events reported accurately? Were the measurements real? Inspections answer these questions.
Good Clinical Practice (GCP)
Full course · Clinical Research Foundations