Providing the Blueprint for Gen AI Adoption in Clinical Trials

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The increased accessibility of generative artificial intelligence (Gen AI) models like OpenAI’s ChatGPT and DALL-E has captured the popular imagination. You’d be hard-pressed now to find any leadership team in any sector that isn’t at least considering ways to leverage Gen AI. 

What Can Institutions with Local IRBs Do to Prepare for the Proposed FDA Single IRB Mandate?

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To comply with the 21st Century Cures Act,1 the U.S. Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to federal regulations. These two NPRMs are intended to harmonize the FDA institutional review board (IRB) and informed consent regulations with the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to the extent possible.