Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices
ABOUT THIS WEBINAR
This webinar will provide background on Investigational New Drug (IND) safety reporting and will introduce listeners to the new guidance entitled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices. Listeners will learn about the new content covered in this guidance.
TOPICS COVERED
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History and overview of 2010 IND Safety Rule and Related Safety Reporting Guidance
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Investigator Reporting to Sponsors for IND Studies:
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Assessment of Causality
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Study Endpoints
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Nonserious Adverse Events
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Investigator Reporting to Institutional Review Boards (IRBs) for IND Studies:
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Adverse Events as Unanticipated Problems That Must be Reported to the IRB
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Other Unanticipated Problems Requiring Reporting to the IRB
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Investigator Reporting to Sponsors and IRBs for Investigational Device Exemption (IDE) Studies
INTENDED AUDIENCE
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Clinical investigators of IND or BA/BE clinical trial studies and of device studies
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Contract Research Organizations working for Sponsors of IND or BA/BE or device clinical trial studies
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Sponsors of IND or BA/BE or device clinical trial studies
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Institutional Review Boards for IND or BA/BE or device clinical trial studies
FDA SPEAKER
Paul M. Gouge, J.D.
Regulatory Counsel
Division of Clinical Trial Quality (DCTQ) | Office of Medical Policy Initiatives (OMPI) | CDER | FDA
FDA RESOURCES
CONTACT
For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707