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Insights Archive

View all entries for: Ask the IRB Experts

  • Insights
    • Insights Archive
      • Ask the IRB Experts
Business woman reviewing document Ask the IRB Experts

What are IRB submission requirements for post marketing safety reports?

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Physician writing note for patient Ask the IRB Experts

May I pay a physician for referring a patient to our study?

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Business person reviewing paperwork late in office. Ask the IRB Experts

What is the IRB’s role in making the nonsignificant risk device determination?

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man working at computer Ask the IRB Experts

Submitting protocol changes to the IRB prior to submitting to FDA

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mother and son in doctors office Ask the IRB Experts

Is IRB review required to collect specimens for a new test to diagnose COVID-19?

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stethoscope on medical document and doctor studying data Ask the IRB Experts

Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB

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Woman with binder explaining to child Ask the IRB Experts

What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?

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Nurse virtually speaking with elderly patient Ask the IRB Experts

What are the regulations for training home health individuals who are working remotely to collect study data?

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doctor with clipboard speaking to elderly patient Ask the IRB Experts

Should Consent Form updates be aligned with Investigator Brochure updates, or wait for next Protocol amendment?

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COVID-19 patient looking out window Ask the IRB Experts

How Should I Handle Changes to Research Made in Response to COVID-19?

Read More about How Should I Handle Changes to Research Made in Response to COVID-19?
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