The Association of Clinical Research Professionals

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ACRP 2025 Expo

Exhibit booth and sponsorship sales are now open for ACRP 2025, held April 24 – 27, New Orleans.

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ACRP Certification

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Latest

Decentralized Clinical Trials Back in the Spotlight Thanks to New FDA Guidance

Just when it seemed as if decentralized clinical trials (DCTs) were in danger of becoming “yesterday’s news” in light of all the attention being paid lately to applications of artificial intelligence in the clinical research enterprise, the tables have turned, if perhaps only briefly, thanks to the release of finalized new U.S. Food and Drug Administration (FDA) regulatory guidance on DCTs. 

Providing the Blueprint for Gen AI Adoption in Clinical Trials

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?

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. 
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Events

Suncoast & Central Florida Chapters: FDA Inspection Preparedness – Everything a Site Needs to Know Pt. 2

Join the Suncoast & Central Florida Chapters for a 2-part virtual event discussing how to prepare for FDA inspections.

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Chicago Chapter: Fall Networking Event

Join the Chicago Chapter for an in-person networking event.

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Wisconsin Chapter: Annual Chapter Conference

Join the Wisconsin Chapter for their annual fall conference held in-person at the University of Wisconsin.  

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