{"id":306,"date":"2023-08-17T03:00:28","date_gmt":"2023-08-17T03:00:28","guid":{"rendered":"https:\/\/research.iium.edu.my\/irec\/?page_id=306"},"modified":"2025-12-15T02:33:50","modified_gmt":"2025-12-15T02:33:50","slug":"post-approval-submission","status":"publish","type":"page","link":"https:\/\/research.iium.edu.my\/irec\/?page_id=306","title":{"rendered":"Post-Approval Submission"},"content":{"rendered":"
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POST-APPROVAL SUBMISSION<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
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Continuing review<\/h5>\n <\/div>\n <\/div>\n
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Process of requesting of review for ethics approval extension. Ethics approval by IREC only valid for one (1) year, therefore investigator need to submit request for continuing review.  Investigator are required to submit Continuing\n Review form one (1) month before the current approval expiry. Continuing Review will take about twenty (20) working days or up to sixty (60) working days if a full-board review is required.<\/span><\/p>\n <\/div>\n <\/div>\n

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Amendment<\/h5>\n <\/div>\n <\/div>\n
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Process of requesting amendment\/modification\/changes on study document after ethics approval was obtained. Investigator are required to submit Amendment form together with every amended document requested. Amendment will take about\n twenty (20) working days or up to sixty (60) working days if a full-board review is required. <\/p>\n

Amendment that is not allowed:\n
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  1. Multiple amendment that include the changes of research title\/type together with other major changes in the research. e.g: Changes of research title and methodology at the same time, changes of research type from pilot to cross-sectional\n research. This kind of amendment is not allowed and applicant is recommended to submit new initial review submission.\n
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  2. Major changes or multiple minor changes (more than 5) that is without Kulliyyah Research Approval (for the changes).<\/li>\n <\/ol>\n

    Amendment will only changes the details of the research while the approval duration will follow the initial approval.<\/p>\n

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    End of study reporting<\/h5>\n <\/div>\n <\/div>\n
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    Process of informing the completion of study and updates the summary on ethical aspect of the study to IREC. IREC will close the file and archive it if the report was satisfactory. Investigator are required to submit End of Study Report\n form together with study abstract\/summary to IREC after the completion of the study. Review and decision on closing of file shall take 10 working days or up to sixty (60) working days if a full-board review is required.<\/p>\n <\/div>\n <\/div>\n

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    Protocol Deviation<\/h5>\n <\/div>\n <\/div>\n
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    Any departure from the study procedures or treatment plans as specified in the IREC-approved protocol. Protocol deviations occur when an investigator does not implement or follow some aspect of a research study as approved by the IREC. Protocol\n Deviation:<\/p>\n

    Minor:<\/p>\n

    Any change, divergence, or departure from the research protocol that has not been approved by the IRB (Institutional Review Board) and that DOES NOT have a major impact on the participant’s rights, safety, or well-being or on the completeness, accuracy, and reliability of the research project data. (Examples include but are not limited to study procedure or participant visit conducted out of period, or blood samples obtained at times close to but not at the time specified in the IRB (Institutional Review Board) approved protocol, or having participants sign a non-stamped consent document, not providing the participant with copies of the consent documents.)<\/span>This\n information should be provided by the Investigator in Continuing Review form or End of Study report whichever necessary. Decision and action will take up to ten (10) working days after the IREC meeting.<\/span><\/p>\n

    Major:<\/p>\n

    Investigator must report to IREC within five (5) working days using Protocol Deviation Form. Decision and action will take twenty (20) working days or up to sixty (60) working days if a full-board review is required. List of Major Protocol Deviation, <\/span>\n read more<\/a>………….<\/p>\n <\/div>\n <\/div>\n

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    Serious Adverse Event<\/h5>\n <\/div>\n <\/div>\n
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    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. An AE can therefore be any unfavourable\n and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Suspected\n Unexpected Serious Adverse Reaction (SUSAR) is considered as SAE.<\/p>\n

    All internal SAEs (occurring in IIUM PI site):<\/span><\/p>\n

    1. Fatal or Life-Threatening SAE\/SUSAR<\/strong><\/p>\n

        Initial report<\/strong>: Within 7 calendar days<\/strong> from the investigator’s awareness of the event.<\/p>\n

        Follow-up report<\/strong>: Within 8 additional calendar days<\/strong> after the initial report <\/p>\n

    2. Non-Fatal\/Non-Life-Threatening SAE\/SUSAR<\/strong><\/p>\n

    \u00b7        Initial report<\/strong>: Within 15 calendar days<\/strong> from the investigator’s awareness of the event <\/p>\n

    External SAE\/SUSARs (occurring in participants at other than IIUM site) need to be notified in a prompt manner if the information impacts the continued ethical acceptability of the trial. This includes cases where the information requires,\n or indicates the need for, a change in the trial protocol or information statement, including changed monitoring<\/p>\n

    All other external SAE\/SUSARs (Overseas) (that do not fit the above criteria) need only be forwarded\/notified if they are suspected and unexpected (i.e., SUSARs) and may be forwarded\/notified as a periodic listing. A periodic listing\n of SUSARs can be up to six (6) month period. Decision and advice will be communicated about ten (10) workings days after IREC Meeting if needed.<\/span><\/p>\n <\/div>\n <\/div>\n

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    Please email the completed form together with the related attachment to irec@live.iium.edu.my with the following subject:<\/p>\n

    Subject: IREC <YEAR>-<ID NUMBER> REQUEST FOR AMENDMENT\n
    Any request without IREC ID will not be entertained. Thank you.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

    POST-APPROVAL SUBMISSION Continuing review Process of requesting of review for ethics approval extension. Ethics approval by IREC only valid for one (1) year, therefore investigator need to submit request for continuing review.  Investigator are required to submit Continuing Review form one (1) month before the current approval expiry. Continuing Review will take about twenty (20) working […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/full-width-page.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/306"}],"collection":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=306"}],"version-history":[{"count":20,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/306\/revisions"}],"predecessor-version":[{"id":3558,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/306\/revisions\/3558"}],"wp:attachment":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}