{"id":3500,"date":"2025-11-20T08:41:48","date_gmt":"2025-11-20T08:41:48","guid":{"rendered":"https:\/\/research.iium.edu.my\/irec\/?page_id=3500"},"modified":"2026-04-23T08:25:27","modified_gmt":"2026-04-23T08:25:27","slug":"required-documents","status":"publish","type":"page","link":"https:\/\/research.iium.edu.my\/irec\/?page_id=3500","title":{"rendered":"Required Documents"},"content":{"rendered":"<div data-colibri-id=\"3500-c1\" class=\"style-2143 style-local-3500-c1 position-relative\">\n  <!---->\n  <div data-colibri-component=\"section\" data-colibri-id=\"3500-c2\" id=\"reusable-sections\" class=\"h-section h-section-global-spacing d-flex align-items-lg-center align-items-md-center align-items-center style-2144 style-local-3500-c2 position-relative\">\n    <!---->\n    <div class=\"h-separator\" style=\"height: 100px; top: calc(0px);\">\n      <svg style=\"fill:rgb(0, 146, 143);\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 2600 130.1\" preserveAspectRatio=\"none\">\n        <polygon points=\"0 130.1 2600 69.1 0 69.1 0 130.1\" opacity=\"0.33\" style=\"isolation:isolate\"><\/polygon>\n        <polygon points=\"0 69.1 2600 69.1 0 0 0 69.1\" opacity=\"0.67\" style=\"isolation:isolate\"><\/polygon>\n        <polygon points=\"0 0 2600 69.1 2600 0 0 0\" style=\"isolation:isolate\"><\/polygon>\n      <\/svg>\n    <\/div>\n    <div class=\"h-separator\" style=\"height: 100px; bottom: calc(0px);\">\n      <svg style=\"fill:rgb(0, 146, 143);transform:rotateX(180deg);\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n        <path class=\"svg-white-bg\" d=\"M761.9,44.1L643.1,27.2L333.8,98L0,3.8V0l1000,0v3.9\"><\/path>\n      <\/svg>\n    <\/div>\n    <div class=\"h-section-grid-container h-section-boxed-container\">\n      <!---->\n      <div data-colibri-id=\"3500-c3\" class=\"h-row-container gutters-row-lg-2 gutters-row-md-2 gutters-row-0 gutters-row-v-lg-2 gutters-row-v-md-2 gutters-row-v-2 style-2145 style-local-3500-c3 position-relative\">\n        <!---->\n        <div class=\"h-row justify-content-lg-center justify-content-md-center justify-content-center align-items-lg-stretch align-items-md-stretch align-items-stretch gutters-col-lg-2 gutters-col-md-2 gutters-col-0 gutters-col-v-lg-2 gutters-col-v-md-2 gutters-col-v-2\">\n          <!---->\n          <div class=\"h-column h-column-container d-flex h-col-lg-auto h-col-md-auto h-col-auto style-2146-outer style-local-3500-c4-outer\">\n            <div data-colibri-id=\"3500-c4\" class=\"d-flex h-flex-basis h-column__inner h-px-lg-2 h-px-md-2 h-px-2 v-inner-lg-2 v-inner-md-2 v-inner-2 style-2146 style-local-3500-c4 position-relative\">\n              <!---->\n              <!---->\n              <div class=\"w-100 h-y-container h-column__content h-column__v-align flex-basis-100 align-self-lg-start align-self-md-start align-self-start\">\n                <!---->\n                <div data-colibri-id=\"3500-c5\" class=\"h-global-transition-all h-heading style-2147 style-local-3500-c5 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-2147 style-local-3500-c5\">\n                    <!---->\n                    <!---->\n                    <h3 class=\"\">REQUIRED DOCUMENT LIST<\/h3>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n      <div data-colibri-id=\"3500-c6\" class=\"h-row-container gutters-row-lg-2 gutters-row-md-2 gutters-row-0 gutters-row-v-lg-2 gutters-row-v-md-2 gutters-row-v-2 style-2148 style-local-3500-c6 position-relative\">\n        <!---->\n        <div class=\"h-row justify-content-lg-center justify-content-md-center justify-content-center align-items-lg-stretch align-items-md-stretch align-items-stretch gutters-col-lg-2 gutters-col-md-2 gutters-col-0 gutters-col-v-lg-2 gutters-col-v-md-2 gutters-col-v-2\">\n          <!---->\n          <div class=\"h-column h-column-container d-flex h-col-lg-6 h-col-md-6 h-col-12 style-2149-outer style-local-3500-c7-outer\">\n            <div data-colibri-id=\"3500-c7\" class=\"d-flex h-flex-basis h-column__inner h-px-lg-2 h-px-md-2 h-px-2 v-inner-lg-2 v-inner-md-2 v-inner-2 style-2149 style-local-3500-c7 position-relative\">\n              <!---->\n              <!---->\n              <div class=\"w-100 h-y-container h-column__content h-column__v-align flex-basis-100 align-self-lg-start align-self-md-start align-self-start\">\n                <!---->\n                <div data-colibri-id=\"3500-c8\" class=\"h-global-transition-all h-heading style-2150 style-local-3500-c8 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-2150 style-local-3500-c8\">\n                    <!---->\n                    <!---->\n                    <h6 class=\"\">Non-clinical Trial study<\/h6>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"3500-c9\" class=\"h-text h-text-component style-2151 style-local-3500-c9 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <ul>\n                      <li>Online Application Form (to be completed at https:\/\/rebs.iium.edu.my\/)<\/li>\n                    <\/ul>\n                    <p>To be uploaded:<\/p>\n                    <ul>\n                      <li>Approval Letter from Kulliyyah Research Committee \/ Head of Institution\/Grant or HOR\/HOD Approval if your Research Committee is not available in your Kulliyyah.<\/li>\n                      <li>CV of Principal Investigator<\/li>\n                      <li>Study Protocol\/Proposal (must include version and date) &#8211;<\/li>\n                      <li>Proforma, case report forms, questionnaires, follow-up cards, etc.(must include version and date).&nbsp;&nbsp;<em>This document must apply de-identification techniques, such as removing or altering direct identifiers (names, addresses) and modifying indirect identifiers (age, gender) to further protect participant privacy. Collect only the minimum amount of data necessary for your research objectives. Avoid gathering excessive or irrelevant information.&nbsp;<\/em>\n                        <a\n                          href=\"https:\/\/research.iium.edu.my\/irec?page_id=1301\"><em>more details<\/em><\/a>\n                      <\/li>\n                      <li>Informed Consent for Study using human (Information Sheet &amp; Consent Form) (must include version and date) if any (\n                        <a href=\"https:\/\/research.iium.edu.my\/irec?page_id=1628\">refer here to learn which research that will require ICF<\/a>)<\/li>\n                      <li>NSCERT Checklist form&nbsp;for study involving Stem Cell Download&nbsp;\n                        <a href=\"https:\/\/liveiiumedu-my.sharepoint.com\/:b:\/g\/personal\/irec_live_iium_edu_my\/EQ7iogytUnhDgCD54LzmNp4BePCg250mqPnYbbVWmbIA3g?e=gTdwvY\" style=\"font-family: &quot;Open Sans&quot;; font-weight: 400; font-size: 1em; color: rgb(0, 102, 204);\"\n                          class=\"customize-unpreviewable\">Link<\/a>\n                      <\/li>\n                      <li>TRAC Checklist Form for study involving Traditional &amp; Complimentary Medicine&nbsp;\n                        <a href=\"https:\/\/drive.google.com\/file\/d\/1Xx1PZpE80GDWipaqwMyC9hpxd0buyn0g\/view?usp=drive_link\" style=\"font-family: &quot;Open Sans&quot;; font-weight: 400; font-size: 1em; color: rgb(0, 102, 204);\"\n                          class=\"customize-unpreviewable\">Link<\/a>\n                      <\/li>\n                      <li><span style=\"font-family: &quot;Open Sans&quot;; font-weight: 400; font-size: 1em; color: rgb(0, 102, 204);\">Research Ethics Approval letter from Host Country (for research conducted outside of Malaysia)<\/span><\/li>\n                      <li>Payment receipt (for external application)<\/li>\n                      <li>Additional Document if any<\/li>\n                      <li>Reply to reviewer comments (PDF format) if it is a resubmission after review.<\/li>\n                    <\/ul>\n                    <p>\n                      <br>\n                    <\/p>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"3500-c10\" class=\"h-x-container style-2152 style-local-3500-c10 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-x-container-inner style-dynamic-3500-c10-group style-2152-spacing style-local-3500-c10-spacing\"><span class=\"h-link__outer style-2153-outer style-local-3500-c11-outer d-inline-flex h-element\"><a h-use-smooth-scroll=\"true\" href=\"https:\/\/research.iium.edu.my\/irec\/?page_id=1153\"  data-colibri-id=\"3500-c11\" class=\"d-flex w-100 align-items-center h-link style-2153 style-local-3500-c11 position-relative\"><!----><span  class=\"h-svg-icon h-link__icon style-2153-icon style-local-3500-c11-icon\"><!--Icon by Font Awesome (https:\/\/fontawesome.com)-->\n    <svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"check\" viewBox=\"0 0 1792 1896.0833\">\n      <path d=\"M1671 566q0 40-28 68l-724 724-136 136q-28 28-68 28t-68-28l-136-136-362-362q-28-28-28-68t28-68l136-136q28-28 68-28t68 28l294 295 656-657q28-28 68-28t68 28l136 136q28 28 28 68z\"><\/path>\n    <\/svg><\/span> <span>How to write research proposal<\/span><\/a>\n                    <\/span>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"3500-c12\" class=\"h-x-container style-2154 style-local-3500-c12 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-x-container-inner style-dynamic-3500-c12-group style-2154-spacing style-local-3500-c12-spacing\"><span class=\"h-link__outer style-2155-outer style-local-3500-c13-outer d-inline-flex h-element\"><a h-use-smooth-scroll=\"true\" href=\"https:\/\/research.iium.edu.my\/irec\/?page_id=1168\"  data-colibri-id=\"3500-c13\" class=\"d-flex w-100 align-items-center h-link style-2155 style-local-3500-c13 position-relative\"><!----><span  class=\"h-svg-icon h-link__icon style-2155-icon style-local-3500-c13-icon\"><!--Icon by Font Awesome (https:\/\/fontawesome.com)-->\n    <svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"check\" viewBox=\"0 0 1792 1896.0833\">\n      <path d=\"M1671 566q0 40-28 68l-724 724-136 136q-28 28-68 28t-68-28l-136-136-362-362q-28-28-28-68t28-68l136-136q28-28 68-28t68 28l294 295 656-657q28-28 68-28t68 28l136 136q28 28 28 68z\"><\/path>\n    <\/svg><\/span> <span>How to write Informed Consent Form<\/span><\/a>\n                    <\/span>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"3500-c14\" class=\"h-x-container style-2156 style-local-3500-c14 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-x-container-inner style-dynamic-3500-c14-group style-2156-spacing style-local-3500-c14-spacing\"><span class=\"h-link__outer style-2157-outer style-local-3500-c15-outer d-inline-flex h-element\"><a h-use-smooth-scroll=\"true\" href=\"https:\/\/research.iium.edu.my\/irec\/?page_id=1628\"  data-colibri-id=\"3500-c15\" class=\"d-flex w-100 align-items-center h-link style-2157 style-local-3500-c15 position-relative\"><!----><span  class=\"h-svg-icon h-link__icon style-2157-icon style-local-3500-c15-icon\"><!--Icon by Font Awesome (https:\/\/fontawesome.com)-->\n    <svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"check\" viewBox=\"0 0 1792 1896.0833\">\n      <path d=\"M1671 566q0 40-28 68l-724 724-136 136q-28 28-68 28t-68-28l-136-136-362-362q-28-28-28-68t28-68l136-136q28-28 68-28t68 28l294 295 656-657q28-28 68-28t68 28l136 136q28 28 28 68z\"><\/path>\n    <\/svg><\/span> <span>Requirement for Informed Consent Form (ICF)<\/span><\/a>\n                    <\/span>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n          <div class=\"h-column h-column-container d-flex h-col-lg-6 h-col-md-6 h-col-12 style-2158-outer style-local-3500-c16-outer\">\n            <div data-colibri-id=\"3500-c16\" class=\"d-flex h-flex-basis h-column__inner h-px-lg-2 h-px-md-2 h-px-2 v-inner-lg-2 v-inner-md-2 v-inner-2 style-2158 style-local-3500-c16 position-relative\">\n              <!---->\n              <!---->\n              <div class=\"w-100 h-y-container h-column__content h-column__v-align flex-basis-100 align-self-lg-start align-self-md-start align-self-start\">\n                <!---->\n                <div data-colibri-id=\"3500-c17\" class=\"h-global-transition-all h-heading style-2159 style-local-3500-c17 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-2159 style-local-3500-c17\">\n                    <!---->\n                    <!---->\n                    <h6 class=\"\">Clinical Trial Study<\/h6>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"3500-c18\" class=\"h-text h-text-component style-2160 style-local-3500-c18 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <ul>\n                      <li>Online Application Form (to be completed at https:\/\/rebs.iium.edu.my\/)<\/li>\n                    <\/ul>\n                    <p>To be uploaded:<\/p>\n                    <ul>\n                      <li>Investigator&#8217;s Brochure<\/li>\n                      <li>CV of Principal Investigator<\/li>\n                      <li>Approval Letter from Kulliyyah Research Committee\/ Institution<\/li>\n                      <li>Any regulatory clearance (study site approval e.g., school) if any<\/li>\n                      <li>Copy of Principal Investigator Good Clinical Practice (GCP) Certificates.<\/li>\n                      <li>Case report form.<\/li>\n                      <li>The study protocol.<\/li>\n                      <li>Informed Consent for Clinical Trial (Information Sheet &amp; Consent Form)<\/li>\n                      <li>Source of funding and financial requirements for the project.<\/li>\n                      <li>A list of Involved staff the trial and their function. (e.g., Nurses, Medical Doctor)<\/li>\n                      <li>Any information of the previous Trials done by others in Malaysia or outside of Malaysia. (If applicable)<\/li>\n                      <li>Copy of Insurance Certificate (IREC will hold Approval Letter until Investigator has submitted the Insurance Certificate copy).<\/li>\n                      <li>List of documents submitted to IREC in EXCEL format. This list will appear in IREC Approval letter.<\/li>\n                      <li>A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related\n                        injuries); a description of the arrangements for insurance coverage for research participants.<\/li>\n                      <li>NSCERT Checklist form. for study involving Stem Cell Download\n                        <a href=\"https:\/\/liveiiumedu-my.sharepoint.com\/:b:\/g\/personal\/irec_live_iium_edu_my\/EQ7iogytUnhDgCD54LzmNp4BePCg250mqPnYbbVWmbIA3g?e=gTdwvY\" class=\"customize-unpreviewable\">Link<\/a>\n                      <\/li>\n                      <li>TRAC Checklist Form for study involving Traditional &amp; Complimentary Medicine\n                        <a href=\"https:\/\/drive.google.com\/file\/d\/1Xx1PZpE80GDWipaqwMyC9hpxd0buyn0g\/view?usp=drive_link\" class=\"customize-unpreviewable\">Link<\/a>\n                      <\/li>\n                      <li>Payment receipt<\/li>\n                    <\/ul>\n                    <p>\n                      <br>\n                    <\/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":"<p>REQUIRED DOCUMENT LIST Non-clinical Trial study Online Application Form (to be completed at https:\/\/rebs.iium.edu.my\/) To be uploaded: Approval Letter from Kulliyyah Research Committee \/ Head of Institution\/Grant or HOR\/HOD Approval if your Research Committee is not available in your Kulliyyah. CV of Principal Investigator Study Protocol\/Proposal (must include version and date) &#8211; Proforma, case report [&hellip;]<\/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\/3500"}],"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=3500"}],"version-history":[{"count":11,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/3500\/revisions"}],"predecessor-version":[{"id":3738,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/3500\/revisions\/3738"}],"wp:attachment":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3500"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}