Navigating the Clinical Protocol Activation Process for Industry Form

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[Music] hello i'm sahal reed senior attorney in medmarks risk management department and i would like to welcome you to medmark's risk management video series on clinical trials part one of this series will provide you with an overview of the clinical trial process which will address questions like does my product require clinical testing in order to be approved by the fda and what are the phases of a clinical trial subsequent videos will delve deeper into the clinical trial process and we'll look at subjects such as the products liability implications of clinical trials informed consent clinical trial agreements irb oversight the clinical trial approval process in the uk canada and the eu and the importance of participant group diversity and clinical trial enrollment first off what are clinical trials and why do they matter per the u.s food and drug administration clinical trials also known as clinical studies test potential treatments and human volunteers to see whether they should be