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Home » EMA Clarifies ‘Triggers’ for For-Cause Versus Routine GCP Inspections
EMA Clarifies ‘Triggers’ for For-Cause Versus Routine GCP Inspections
August 28, 2013
As drug sponsors make their way through the EU approval process, there are “triggers” that can help European Medicines Agency inspection coordinators determine whether a clinical trial should undergo a routine or for-cause good clinical practice inspection, an agency working group says. Determining factors include trial size, complexity and site selection.