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Ask The Experts Insights

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Ask the Experts

What are the requirements for notifications of study closure at research sites?

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Ask the Experts

Do all subjects need to be reconsented with the revised consent form?

Read More about Do all subjects need to be reconsented with the revised consent form?
Ask the Experts

Can a protocol get IRB approval during the 30-day IND waiting period?

Read More about Can a protocol get IRB approval during the 30-day IND waiting period?
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Does my customer survey project require IRB review?

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Can you use patient Electronic Health Records to identify and recruit subjects?

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Informed Consent on tablet Ask the Experts

Is informed consent needed for post-market patient registry?

Read More about Is informed consent needed for post-market patient registry?
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Does the IRB need to approve doctor-to-doctor letters?

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What are the IRB review requirements for human factors/usability testing?

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Ask the Experts

Can a physician submit a single humanitarian use device (HUD) submission to the IRB?

Read More about Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
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What questions can be asked when screening patients prior to them signing consent?

Read More about What questions can be asked when screening patients prior to them signing consent?
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