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Drafting a Research Plan for IRB Review and Research Conduct: Information that Must Be Included in a Clinical Trial Protocol
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What are the requirements for notifications of study closure at research sites?
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Do all subjects need to be reconsented with the revised consent form?
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Can a protocol get IRB approval during the 30-day IND waiting period?
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The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
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Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
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Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
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What documentation needs to be submitted to the IRB for an IND exemption request?
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