Fda Review Insights

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

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Reviewing the FDA’s Proposed Single IRB Mandate

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Reviewing the FDA’s Proposed Informed Consent Rule Changes

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Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans

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Assessing Potential Risks in the Consideration of IND Exemption Criteria

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Defining “Minimal Risk” in Clinical Research

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Which comes first – IRB or IBC approval?

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Approval of an Investigational New Drug Study

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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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