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    Sai Tharun Thodupunuru
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    This document summarizes serious adverse event reporting requirements according to different regulatory authorities. It outlines that the FDA, MHRA, European Commission, and CDSCO all have slightly different timelines for investigators, sponsors, ethics committees and regulatory authorities to report initial and follow up SAE information, ranging from 24 hours to 15 days. The document provides a helpful overview of international SAE reporting guidelines.

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    This document summarizes serious adverse event reporting requirements according to different regulatory authorities. It outlines that the FDA, MHRA, European Commission, and CDSCO all have slightly different timelines for investigators, sponsors, ethics committees and regulatory authorities to report initial and follow up SAE information, ranging from 24 hours to 15 days. The document provides a helpful overview of international SAE reporting guidelines.

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    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
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    7 views8 pages

    Reporting SAE

    Uploaded by

    Sai Tharun Thodupunuru
    This document summarizes serious adverse event reporting requirements according to different regulatory authorities. It outlines that the FDA, MHRA, European Commission, and CDSCO all have slightly different timelines for investigators, sponsors, ethics committees and regulatory authorities to report initial and follow up SAE information, ranging from 24 hours to 15 days. The document provides a helpful overview of international SAE reporting guidelines.

    Copyright:

    Attribution Non-Commercial (BY-NC)
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    of 8

    REPORTING OF SAE

    INDEX:

    ABBREVATIONS ACCORDING TO FDA REGULATION ACCORDING TO MHRA REGULATION ACCORDING TO EUROPEAN COMMISSION REGULATION ACCORDING TO CDSCO REGULATION

    ABBREVATIONS:

    SAE Serious Adverse Events FDA Food and Drug Administration (United states of america) MHRA Medicines and Health care products Regulatory Agency (United kingdom) CDSCO Central Drugs Standard Control Organization (India)

    FDA
    ETHICS COMMITTEE 7 DAYS

    OTHER INVESTIGATO RS

    15 WORKING DAYS

    SPONSOR

    7 CALENDER REGULATO DAYS RY (INTIAL) 15CALENDERDAYS AUTHORITY (FOLLOW UP)

    24HOURS DAYS 15 (INTIAL) (FOLLOW UP) ETHICS COMMITTE E

    INVESTIGATOR

    7 WORKINGDAYS

    MHRA
    ETHICS COMMITTEE 8 DAYS (FOLLOW UP) 7 DAYS (INTIAL) 7 DAYS 15 DAYS (1ST FOLLOW UP) 8 DAYS ( 2ND FOLLOW UP) 7 DAYS (INTIAL)

    OTHER INVESTIGATO RS

    SPONSOR 8 DAYS (INTIAL (FOLLOW UP) ) 24HOURS DAYS 15 (INTIAL) (FOLLOW UP)

    REGULATO RY AUTHORITY

    INVESTIGATOR

    7 DAYS

    ETHICS COMMITTE E

    EUROPEAN COMMISSION
    ETHICS COMMITTEE 7 DAYS 8 DAYS (INTIAL)(FOLLOW UP) OTHER INVESTIGAT ORS 15 DAYS (1ST FOLLOW UP) 8 DAYS ( 2ND FOLLOW UP) 7 DAYS (INTIAL)

    7 DAYS (INTIAL 8 DAYS ) (FOLLOW UP)

    SPONSOR

    REGULATO RY AUTHORIT Y

    48 HOURS 15 DAYS (INTIAL) (FOLLOW UP) INVESTIGATOR 7 DAYS ETHICS COMMITTEE

    CDSCO
    ETHICS COMMITTEE 7 WORKING DAYS 14 OTHER CALENDER INVESTIGAT DAYS ORS

    SPONSOR

    14 CALENDER REGULATO DAYS RY AUTHORIT Y

    24 HOURS 15 DAYS (INTIAL) (FOLLOW UP) ETHICS COMMITTEE

    INVESTIGATOR

    7 WORKING DAYS

    THANK YOU

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