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    Ich Guidelines: Harmonising For Better Health

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    Sathish Kumar
    This document provides guidelines on clinical safety data management and standards for expedited reporting. It defines key terms like adverse event, adverse drug reaction, expected and unexpected reactions. It outlines what should be reported expeditiously like serious and unexpected adverse drug reactions. Reporting timeframes are specified as no later than 7 or 15 days. Minimum criteria for reporting and how to report using CIOMS-I form are explained. Key data elements for expedited reports like patient details, suspected products, reaction details are also defined.

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    Ich Guidelines: Harmonising For Better Health

    Uploaded by

    Sathish Kumar
    13 views20 pages
    This document provides guidelines on clinical safety data management and standards for expedited reporting. It defines key terms like adverse event, adverse drug reaction, expected and unexpected reactions. It outlines what should be reported expeditiously like serious and unexpected adverse drug reactions. Reporting timeframes are specified as no later than 7 or 15 days. Minimum criteria for reporting and how to report using CIOMS-I form are explained. Key data elements for expedited reports like patient details, suspected products, reaction details are also defined.

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    ICH_E2A_SATHISH

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    This document provides guidelines on clinical safety data management and standards for expedited reporting. It defines key terms like adverse event, adverse drug reaction, expected and unexpected reactions. It outlines what should be reported expeditiously like serious and unexpected adverse drug reactions. Reporting timeframes are specified as no later than 7 or 15 days. Minimum criteria for reporting and how to report using CIOMS-I form are explained. Key data elements for expedited reports like patient details, suspected products, reaction details are also defined.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    13 views20 pages

    Ich Guidelines: Harmonising For Better Health

    Uploaded by

    Sathish Kumar
    This document provides guidelines on clinical safety data management and standards for expedited reporting. It defines key terms like adverse event, adverse drug reaction, expected and unexpected reactions. It outlines what should be reported expeditiously like serious and unexpected adverse drug reactions. Reporting timeframes are specified as no later than 7 or 15 days. Minimum criteria for reporting and how to report using CIOMS-I form are explained. Key data elements for expedited reports like patient details, suspected products, reaction details are also defined.

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    ICH GUIDELINES

    HARMONISING FOR BETTER HEALTH

    BY
    T.SATHISH KUMAR
    PHARMACOVIGILANCE
    CLINICAL SAFETY DATA MANAGEMENT:
    DEFINITIONS AND STANDARDS FOR
    EXPEDITED REPORTING
    (E2A)
    CONTENTS

     INTRODUCTION
     DEFINITIONS AND TERMINOLOGY
     STANDARDS FOR EXPEDITED REPORTING
     DATA ELEMENTS FOR EXPEDITED REPORTS
    INTRODUCTION

     Ensure uniform Good Clinical Practice standards in drug


    developmental stage
     The development of standard definitions and terminology for
    key aspects of clinical safety reporting
     For appropriate mechanism for handling expedited (rapid)
    reporting, in the investigational phase
    DEFINITIONS AND TERMINOLOGY ASSOCIATED
    WITH CLINICAL SAFETY EXPERIENCE

    A d ve rs e   Eve nt   ( o r   A d ve rs e E x p e r i e n c e )

    Any untoward medical occurrence in a patient or


    clinical investigation subject administered a pharmaceutical
    product and which does not necessarily have a causal
    relationship with this treatment
    DEFINITIONS AND TERMINOLOGY ASSOCIATED
    WITH CLINICAL SAFETY EXPERIENCE

    A d ve rs e   D r u g   Re a c ti o n ( A D R )

    In the pre-approval clinical experience :


    All noxious and unintended responses to a
    medicinal product related to any dose should be considered
    adverse drug reactions
    DEFINITIONS AND TERMINOLOGY ASSOCIATED
    WITH CLINICAL SAFETY EXPERIENCE
    E x p e c t e d   A d v e r s e   D r u g   R e a c ti o n

    An adverse reaction, the nature or severity of which is


    consistent with the applicable product information (Investigator's Brochure)

    U n e x p e c t e d   A d v e r s e   D r u g   R e a c ti o n
    An adverse reaction, the nature or severity of which is not
    consistent with the applicable product information (Investigator's
    Brochure)
    DEFINITIONS AND TERMINOLOGY ASSOCIATED
    WITH CLINICAL SAFETY EXPERIENCE
    S e r i o u s   A d ve rs e   Eve nt   o r re a c ti o n
    A serious adverse event (experience) or reaction is any
    untoward medical occurrence that at any dose
    - results in death
    - is life-threatening
    - requires inpatient hospitalisation or prolongation of
    existing hospitalisation
    - results in persistent or significant disability/incapacity
    - congenital anomaly/birth defect
    STANDARDS FOR EXPEDITED REPORTING

    What Should be Reported

     Single Cases of Serious, Unexpected ADRs


     Reports from spontaneous sources and from any type of clinical or
    epidemiological investigation
     Source should be specified always
     Reasonable suspected causal relationship to the medicinal product
    qualify as ADRs
    STANDARDS FOR EXPEDITED REPORTING

    O t h e r O b s e r vati o n s

     lack of efficacy
     Increase in the rate of occurrence of an expected serious
    ADR
     Newly completed animal study
    STANDARDS FOR EXPEDITED REPORTING
    Re p o r ti n g   T i m e   F ra m e s

    Fatal or Life-Threatening Unexpected ADR


     Should be notified as soon as possible but no later than 7
    calendar days after first knowledge by the sponsor
     Complete report as possible within 8 additional calendar
    days
    STANDARDS FOR EXPEDITED REPORTING

    Re p o r ti n g   T i m e   F ra m e s

    All Other Serious, Unexpected ADRs


     No later than 15 calendar days after first knowledge by the
    sponsor
    STANDARDS FOR EXPEDITED REPORTING
    M i n i m u m c r i te r i a fo r re p o r ti n g

     An identifiable patient
     Suspect medicinal product
     An identifiable reporting source
     And an event or outcome (SUSAR)
    STANDARDS FOR EXPEDITED REPORTING
    H o w   to   Re p o r t

     The CIOMS-I is standard for expedited adverse event reporting


     Reports must be sent to regulatory or other official parties
    requiring them in countries where the drug is under
    development
     Informing investigators and ethics committees/ institutional
    review boards of new safety information
    KEY DATA ELEMENTS FOR EXPEDITED
    REPORTS OF SERIOUS ADVERSE DRUG REACTIONS

    Pati e nt   D e ta i l s
     Initials
     Other relevant identifier (clinical investigation number, for
    example)
    - Gender
    - Age and/or date of birth
    - Weight
    - Height
    KEY DATA ELEMENTS FOR EXPEDITED
    REPORTS OF SERIOUS ADVERSE DRUG REACTIONS

    S u s p e c te d   M e d i c i n a l   P ro d u c t ( s )
     Brand name as reported
     International Non-Proprietary Name (INN)
     Indication(s) for which suspect medicinal product
     Dosage form and strength
     Route of administration

    Other Treatment(s)
     concomitant medicinal products
    KEY DATA ELEMENTS FOR EXPEDITED
    REPORTS OF SERIOUS ADVERSE DRUG REACTIONS

    D e ta i l s   o f   S u s p e c te d   A d ve rs e   D r u g   Re a c ti o n

     Start date (and time) of onset of reaction


     Stop date (and time) or duration of reaction
     Dechallenge and rechallenge information
     Outcome
    KEY DATA ELEMENTS FOR EXPEDITED
    REPORTS OF SERIOUS ADVERSE DRUG REACTIONS

    Other details
     Details on Reporter of Event
      Administrative and Sponsor/Company Details
    THANKYOU

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