Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more
9/20/2021
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Clinical Trials ,
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Personal Data ,
Personally Identifiable Information ,
Privacy Laws ,
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South Korea
Recognizing the impact that COVID-19 can have on research and the NIH grant application process, the NIH has issued 5 pieces of guidance between March 9 and 16, 2020 addressing various impacts of COVID-19 on NIH research...more
The FDA this month released guidance surrounding the conduct of clinical trials involving medical products during the COVID-19 pandemic.
The key themes of the guidance are (i) protect the health and safety of trial staff...more