Spring Intro 2023

16/02/2023

Common study designs and their application

The Organisation for Professionals in Regulatory Affairs

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Important terminology

• “Blinding” means that the identity of study treatment remains unknown, even after randomisation • In a “double-blind” study, neither the investigator nor the patient knows which treatment group they have been assigned to

• “Bias” can be conscious or sub-conscious • It is essential to minimise the potential for bias that might affect the conclusions drawn from a clinical trial

The Organisation for Professionals in Regulatory Affairs

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