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Tag: FDA regulations

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IRB

Guidance Document Summary: Unpacking FDA’s Guidance Document on Informed Consent

(PRIM&R) Public Responsibility in Medicine and Research

The FDA issued guidance in August 2023 to provide more clarity to IRBs, clinical investigators, and sponsors in complying with FDA’s informed…

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Navigating FDA-Regulated Research as an IRB

(PRIM&R) Public Responsibility in Medicine and Research

On May 3, 2022, PRIM&R hosted a webinar, Un-Common Rules: Navigating FDA-Regulated Research and the IRB. During the webinar, Belinda…

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A stack of books titled Rules and Regulations
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No fear, just proper preparation–IRB Professionals and the FDA

(PRIM&R) Public Responsibility in Medicine and Research

Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed…

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Expanded Access in the time of COVID-19: What do IRBs need to know?

(PRIM&R) Public Responsibility in Medicine and Research

The COVID-19 pandemic has brought many issues to the public’s attention that used to be of interest only to clinical…

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Webinar Follow-up: Data and Safety Monitoring: Advanced Issues and Case Studies

(PRIM&R) Public Responsibility in Medicine and Research

In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.