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  • Form SAF01.1 - Safety Assessment and Reporting Guideline

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    Anusha
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    1. The document outlines safety assessment and reporting guidelines for a clinical trial, including processes for eliciting and managing adverse event reports. 2. Adverse events will be assessed throughout the trial, recorded whether spontaneously reported or observed, and elicited through general questions to participants. 3. Serious adverse events will be reported by the investigator to the sponsor within 24 hours, and the sponsor is responsible for reporting these events to regulatory authorities within certain timelines.

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    Form SAF01.1_Safety assessment and reporting guideline

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    1. The document outlines safety assessment and reporting guidelines for a clinical trial, including processes for eliciting and managing adverse event reports. 2. Adverse events will be assessed throughout the trial, recorded whether spontaneously reported or observed, and elicited through general questions to participants. 3. Serious adverse events will be reported by the investigator to the sponsor within 24 hours, and the sponsor is responsible for reporting these events to regulatory authorities within certain timelines.

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    © All Rights Reserved
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    Download as docx, pdf, or txt
    34 views2 pages

    Form SAF01.1 - Safety Assessment and Reporting Guideline

    Uploaded by

    Anusha
    1. The document outlines safety assessment and reporting guidelines for a clinical trial, including processes for eliciting and managing adverse event reports. 2. Adverse events will be assessed throughout the trial, recorded whether spontaneously reported or observed, and elicited through general questions to participants. 3. Serious adverse events will be reported by the investigator to the sponsor within 24 hours, and the sponsor is responsible for reporting these events to regulatory authorities within certain timelines.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    Download as docx, pdf, or txt
    of 2

    SAF01.

    1 Safety assessment and reporting guideline Page __ of __

    Safety assessment and reporting


    Site name
    guideline

    Trial number Sponsor

    Process for elicitation and management of adverse event (AE) reports:


    1. AEs will be assessed from screening throughout the trial
    2. AEs will be recorded whether spontaneously reported by participants, observed by the trial staff or elicited by
    general questioning
    3. AEs will be elicited by indirect questioning (no leading questions) during study days, with such questions as “How
    are you?” or “Is anything bothering you?”
    4. Abnormal findings will be carefully considered and any participant who, in the judgment of the investigator may
    not safely complete the study, will be withdrawn
    5 AEs will be followed up until resolution or agreement between the PI and the Sponsor Medical Monitor
    6. SAEs, non-serious unexpected reactions and changes in nature, severity or frequency of risk factors, and new
    information impacting the risk/benefit profile – see overleaf for Process flow for management of SAE reports
    SAF01.1 Safety assessment and reporting guideline Page __ of __

    Process flow for management of SAE reports

    Site responsibilities
    Investigator submits SAE form to sponsor within 24 hours of knowledge:
     Sponsor Pharmacovigilance dept. contact details:
     Sponsor Medical Monitor contact details:
    NB a life-threatening or fatal event will also be communicated within 2 hours of knowledge by phone
    A preliminary causality assessment is performed by the investigator

    Pharmacovigilance dept. receipt Medical monitor receipt


    (Within 1 working day of initial receipt) (Within 1 working day of initial receipt)
    Confirm receipt of SAE form to site Assess if life-threatening/fatal SUSAR
    Check whether case is valid Assess whether there is a reason to stop study
    Communicates with Sponsor as such

    Pharmacovigilance dept. initial assessment


    (Within 1 working day of initial receipt)
    Triage case, MedDRA coding, case and causality Pharmacovigilance dept/QC
    assessment (7-day report by day 4, 15-day reports by day 6, otherwise by
    Send initial assessment form to Medical Monitor day 6)
    Data entry/QC/generation of CIOMS 1 report sent to Medical
    Monitor for review and approval
    Medical assessment
    (7-day report - within 1 working day, otherwise
    3)
    Confirmation of case assessment and sponsor
    causality assessment
    Medical monitor final review
    (7-day report by day 4, otherwise by day 8)
    Review and comment on CIOMS 1 - returned to sponsor
    Send request for case follow up to investigator pharmacovigilance dept

    Case tracking and filing

    Sponsor case finalised


    Sponsor sends report to regulatory authorities by day 6 for life-threatening/fatal SUSARs, by day 13 for all other expedited
    SUSARs (with copy to investigator)
    Sponsor sends CIOMS form to investigator for submission to HREC by day 6 (7-day reports) or 13 (15-day reports)

    Site submission to HREC EVENTS OTHER THAN SUSARs


    Site sends CIOMS form to REC by day 7 Sponsor sends to site 6 monthly for
    or 15 as relevant submission to regulatory authority/HREC:
    - List of all SAEs worldwide
    - List of non-serious unexpected reactions
    worldwide
    Site submission to DSMB/other necessary notifications
    Site sends CIOMS to DSMB according to Charter:
    - Ad-hoc meetings for specific safety concerns, otherwise, at routine meetings

    Site sends to regulatory authority and HREC:


    - Notification of change in nature, severity or frequency of risk factors (within 15
    days and in 6 monthly reports)

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