[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-196952-105":3,"detail-sidebar-cat-1-en-105":80,"doc-detail-196952-en":126},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":73,"head_meta":75,"extra_data":77,"updated_unix":79},105,"en","guidance-to-submit-complete-investigators-documents-complete-investigator-submission-requirements","Guidance to Submit Complete Investigators Documents - Complete Investigator Submission Requirements","","Guidance outlining the required “Investigator’s documents” for research submission to MREC. It specifies that investigators must provide the IA-HOD-IA form, a complete Curriculum Vitae (CV), a Good Clinical Practice (GCP) certificate for all investigators in an interventional study, and a Declaration of Conflict of Interest (COI) by the Corresponding Principal Investigator. The guidance also clarifies which items are needed for initial approval versus amendment when investigators are added, removed, roles change, or study sites change.",{"@graph":14,"@context":72},[15,34,55],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/guidance-to-submit-complete-investigators-documents-complete-investigator-submission-requirements/196952/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/guidance-to-submit-complete-investigators-documents-complete-investigator-submission-requirements/196952.png","ImageObject",442,249,{"name":42,"@type":43},"Gloria","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-02","2026-09-03",true,{"@type":52,"interactionType":53,"userInteractionCount":33},"InteractionCounter",{"@type":54},"ViewAction",{"@type":56,"mainEntity":57},"FAQPage",[58,64,68],{"name":59,"@type":60,"acceptedAnswer":61},"Which documents are required for all research submitted to MREC by investigators?","Question",{"text":62,"@type":63},"The submission requires the IA-HOD-IA form, a complete Curriculum Vitae (CV) for each investigator, and a Declaration of Conflict of Interest (COI) by the Corresponding Principal Investigator on behalf of the study team.","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"Is a GCP certificate required for every study type and every investigator?",{"text":67,"@type":63},"A Good Clinical Practice (GCP) certificate is required for all investigators in an interventional study. It indicates successful participation in a Malaysian GCP workshop and issuance follows the workshop exit exam.",{"name":69,"@type":60,"acceptedAnswer":70},"What investigator documents must be updated during amendments?",{"text":71,"@type":63},"Amendments require updated documents when additional investigators are added, and the COI declaration must be completed by the Corresponding Principal Investigator if there is any addition/removal of investigators, a change of investigator roles, or a change of investigators’ sites.","https://schema.org",{"og:url":32,"og:type":74,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":76,"canonical":32},"index,follow",{"doc_id":78,"site_id":7},196952,1788463839,{"code":4,"msg":81,"data":82},"success",[83,88,93,98,103,108,112,117,122],{"id":84,"doc_module":22,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},11,"Presentations",90,"presentations",{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":110,"slug":111},17,40,"forms",{"id":113,"doc_module":22,"doc_module_name":25,"category_name":114,"show_sort_weight":115,"slug":116},18,"Letters",30,"letters",{"id":118,"doc_module":22,"doc_module_name":25,"category_name":119,"show_sort_weight":120,"slug":121},21,"Paper Templates",5,"papers-templates",{"id":123,"doc_module":22,"doc_module_name":25,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158",{"code":4,"msg":81,"data":127},{"doc_id":78,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":109,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":33,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":22,"language":135,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":12,"update_tm":79,"read_time":4},2336474459895,"https://ap-avatar.wpscdn.com/avatar/22000baeef7a5ed0655?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786071322749376916","|  | Document Name | Definition of Document |\n| --- | --- | --- |\n| Investigator’s documents |  |  |\n| 1. | IA-HOD-IA form | Required for all research submitted to MREC.\u003Cbr>Investigator's agreement, head of departments and institutional approval |\n| 2. | Curriculum Vitae (CV) | Required for all research submitted to MREC.\u003Cbr>A summary of the investigator’s education, professional history, and job qualifications or other documentation evidencing the investigator’s qualifications. To be completed for all investigators. |\n| 3. | Good Clinical Practice (GCP) certificate | Required for all investigators in an Interventional Study\u003Cbr>The certificate indicating successful participation in a Malaysian GCP workshop. The certificate is issued upon passing the workshop exit exam. |\n| 4. | Declaration of Conflict of Interest (COI) by Principal Investigator | Required for all research submitted to MREC.\u003Cbr>Document to be completed by the Corresponding Principal Investigator on behalf of the study team to declare any conflict of interest. This document should include list of ALL existing study investigators, their roles in the study and their respective study sites. |\n\n\n|  |  | Initial Approval | Amendment |\n| --- | --- | --- | --- |\n| 1. | IA-HOD-IA | To be completed for all Principal Investigators (including Coordinating PI and PI at site) | Needed if any addition/changes of principal investigators (including Coordinating PI and PI at site) |\n| 2. | Curriculum Vitae (CV) | To be completed for all\u003Cbr>investigators. | Needed for any additional investigator(s) |\n| 3. | Good Clinical Practice (GCP) certificate | Required for all investigators in an interventional study | Needed for any additional investigators in an interventional study |\n| 4. | Declaration of Conflict of Interest (COI) by Principal Investigator | To be completed by the Corresponding Principal Investigator on behalf of the study team to declare any conflict of interest. | To be completed by Corresponding PI if any:\u003Cbr>􀁸 addition/removal of investigators\u003Cbr>􀁸 change of role\u003Cbr>􀁸 change of investigators’ site |","cbCais3xD1tHfZq9","https://ap.wps.com/l/cbCais3xD1tHfZq9","pdf",271196,"English","# Required Investigator Documents\n## IA-HOD-IA form\n## Curriculum Vitae (CV)\n## Good Clinical Practice (GCP) certificate\n## Declaration of Conflict of Interest (COI)\n# Initial Approval vs Amendment Requirements","[{\"question\":\"Which documents are required for all research submitted to MREC by investigators?\",\"answer\":\"The submission requires the IA-HOD-IA form, a complete Curriculum Vitae (CV) for each investigator, and a Declaration of Conflict of Interest (COI) by the Corresponding Principal Investigator on behalf of the study team.\"},{\"question\":\"Is a GCP certificate required for every study type and every investigator?\",\"answer\":\"A Good Clinical Practice (GCP) certificate is required for all investigators in an interventional study. It indicates successful participation in a Malaysian GCP workshop and issuance follows the workshop exit exam.\"},{\"question\":\"What investigator documents must be updated during amendments?\",\"answer\":\"Amendments require updated documents when additional investigators are added, and the COI declaration must be completed by the Corresponding Principal Investigator if there is any addition/removal of investigators, a change of investigator roles, or a change of investigators’ sites.\"}]","Guidance to Submit Complete Investigators Documents - Complete Investigator Submission Requirements | PDF"]