Regional forum of clinical trial regulators 

"The primary goal of clinical trial oversight is to protect the safety and rights of human participants, ensuring that studies are properly designed to achieve scientifically valid objectives and to prevent any possibility of fraud or data falsification.

Studies involving health products that will lead to a new marketing authorization or a modification of an existing authorization must obtain prior approval from Ethics Committees and National Regulatory Authorities (NRAs) before initiation. NRAs are responsible for critically evaluating the documentation supporting clinical trials for registration purposes at two key stages:

1. During the application for authorization to conduct the clinical trial, and monitoring throughout its execution.
2. When evaluating an application for marketing authorization of the product."

Source: WHO Global Benchmarking Tool for Evaluating National Regulatory Systems for Medical Products