Regulatory Open Forum

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  • 1.  IND Safety Reporting

    Posted 12-Mar-2014 15:46
    Does anybody know the difference between a "serious" adverse event and a "life-threatening" adverse event? Thank you!

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    Ranyang Li
    Process Development Engineer
    Tissuegene, Inc
    Rockville MD
    United States
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  • 2.  RE:IND Safety Reporting

    Posted 12-Mar-2014 16:24
    If I tell you what I personally think it is/should be, it will be nothing more or less than a "dime a dozen."

    I will quote how FDA understands here.

    Simply put, "Serious Adverse Events" refer to death, life-threatening events, disability, permanent damage, hospitalization, events requiring medical intervention.

    "Life-threatening events" refer to those when the patient was at substantial risk of dying a the time of the adverse event.  

    As a practical matter, because of some level of subjectivity when interpreting the terms, "life-threatening" events may not necessarily be "black and white" issue.   


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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 3.  RE:IND Safety Reporting

    Posted 12-Mar-2014 16:38
    Specifically for IND safety reporting purposes, I would refer to:

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32


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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 4.  RE:IND Safety Reporting

    Posted 13-Mar-2014 22:08
    By definition, a life -threatening event is an SAE. It is important that your safety monitors and medical monitors have the same definition and understanding of SAEs so reporting requirements are met. The medical assessment of any SAE as it relates to your investigational agent is critical and will result in a more accurate safety profile when your medical monitor or monitors and Safety CRO if used understand the expected safety profile. Relatedness is critical for reporting purposes and differs slightly between the US and EU. Make sure to read both guidances and understand the definitions for reporting purposes. All the best, Dar ------------------------------------------- Darlene Rosario Principal Consultant RA, Quality and Compliance Velocity Consulting Ventura CA United States -------------------------------------------
    Original Message