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

• History and overview of 2010 IND Safety Rule and Related Safety Reporting Guidance 

• Investigator Reporting to Sponsors for IND Studies: 

• Assessment of Causality 

• Study Endpoints 

• Nonserious Adverse Events 

• Investigator Reporting to Institutional Review Boards (IRBs) for IND Studies: 

• Adverse Events as Unanticipated Problems That Must be Reported to the IRB 

• Other Unanticipated Problems Requiring Reporting to the IRB 

• Investigator Reporting to Sponsors and IRBs for Investigational Device Exemption (IDE) Studies 

INTENDED AUDIENCE

• Clinical investigators of IND or BA/BE clinical trial studies and of device studies 

• Contract Research Organizations working for Sponsors of IND or BA/BE or device clinical trial studies 

• Sponsors of IND or BA/BE or device clinical trial studies 

• 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

• FDA IND Safety Reporting Website

• Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices 

 

CONTACT

For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707