{"id":955,"date":"2025-04-29T07:27:15","date_gmt":"2025-04-29T06:27:15","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=955"},"modified":"2025-04-29T12:31:36","modified_gmt":"2025-04-29T11:31:36","slug":"clinical-trials-under-us-regulation","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/clinical-trials-under-us-regulation\/","title":{"rendered":"Clinical Trials under US Regulation"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:16px;--awb-text-transform:none;--awb-text-color:var(--awb-color1);--awb-text-font-family:&quot;Source Sans Pro&quot;;--awb-text-font-style:normal;--awb-text-font-weight:700;\" id=\"navigacija_naslov\"><p>Medicinal Products<\/p>\n<\/div><nav 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awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/search-for-the-approved-clinical-trials\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for the approved clinical trials<\/span><\/a><\/li><li  id=\"menu-item-357\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-357 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"357\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/search-for-import-licenses\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for import licenses<\/span><\/a><\/li><\/ul><\/nav><\/div><\/div>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.56%;--awb-width-medium:75%;--awb-order-medium:0;--awb-spacing-right-medium:2.56%;--awb-spacing-left-medium:2.56%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\"><h1 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><strong>Use of FDA 1572 form for clinical trials in Rebublic Serbia (RS)<\/strong><\/h1><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;width:100%;\"><div class=\"fusion-separator-border sep-double\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;border-bottom-width:1px;\"><\/div><\/div><div class=\"accordian fusion-accordian\" style=\"--awb-border-size:1px;--awb-icon-size:12px;--awb-content-font-size:var(--awb-typography4-font-size);--awb-icon-alignment:left;--awb-hover-color:var(--awb-color2);--awb-border-color:var(--awb-color3);--awb-background-color:var(--awb-color1);--awb-divider-color:var(--awb-color3);--awb-divider-hover-color:var(--awb-color3);--awb-icon-color:var(--awb-color1);--awb-title-color:var(--awb-color8);--awb-content-color:var(--awb-color8);--awb-icon-box-color:var(--awb-color4);--awb-toggle-hover-accent-color:var(--awb-color4);--awb-title-font-family:var(--awb-typography1-font-family);--awb-title-font-weight:var(--awb-typography1-font-weight);--awb-title-font-style:var(--awb-typography1-font-style);--awb-title-font-size:20px;--awb-content-font-family:var(--awb-typography4-font-family);--awb-content-font-weight:var(--awb-typography4-font-weight);--awb-content-font-style:var(--awb-typography4-font-style);\"><div class=\"panel-group fusion-toggle-icon-boxed\" id=\"accordion-955-1\"><div class=\"fusion-panel panel-default panel-6a862ab9002aaaa55 fusion-toggle-has-divider\" style=\"--awb-title-color:var(--awb-color8);\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_6a862ab9002aaaa55\"><a aria-expanded=\"false\" aria-controls=\"6a862ab9002aaaa55\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-955-1\" data-target=\"#6a862ab9002aaaa55\" href=\"#6a862ab9002aaaa55\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Abbreviations<\/span><\/a><\/h4><\/div><div id=\"6a862ab9002aaaa55\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_6a862ab9002aaaa55\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><em><strong>FDA<\/strong>\u00a0 &#8211;\u00a0 Food and Drug Administration<\/em><\/p>\n<p><em><strong>CFR<\/strong>\u00a0 &#8211;\u00a0 Code of Federal Regulations<\/em><\/p>\n<p><em><strong>GCP<\/strong>\u00a0 &#8211;\u00a0 Good Clinical Practice<\/em><\/p>\n<p><em><strong>IND<\/strong>\u00a0 &#8211;\u00a0 Investigational New Drugs<\/em><\/p>\n<p><em><strong>RBI<\/strong>\u00a0 &#8211;\u00a0 Institutional Review Board<\/em><\/p>\n<p><em><strong>CT<\/strong>\u00a0 &#8211;\u00a0 Clinical Trial<\/em><\/p>\n<p>Do investigators in CTs have to sign a 1572 form and is it consistent with RS local regulations to conduct a clinical trial in RS under United States (US) Investigational New Drug (IND) regulations?<\/p>\n<p>No, the investigators in the RS cannot fulfill the requirements stated in the form 1572. The clinical trial conducted at the sites in the RS cannot be conducted under any law of a foreign country. CT must be carried out in accordance with the national legislation specified in the Law and subsequent by-laws:<\/p>\n<ul>\n<li><em>Law on Medicines and Medical Devices (&#8220;Official Gazette of the RS&#8221;, no. 30\/2010 and 107\/2012, 105\/17-dr.zakon, 113\/2017 &#8211; dr.zakon)<\/em><\/li>\n<li><em> Rulebook on clinical trials of drugs in human medicine (&#8220;Official Gazette of RS&#8221;, no. 51\/2022, 65\/2023, 86\/2023)<\/em><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-a38b4480a698e812d fusion-toggle-has-divider\" style=\"--awb-title-color:var(--awb-color8);\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_a38b4480a698e812d\"><a aria-expanded=\"false\" aria-controls=\"a38b4480a698e812d\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-955-1\" data-target=\"#a38b4480a698e812d\" href=\"#a38b4480a698e812d\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Problem\/Clarification<\/span><\/a><\/h4><\/div><div id=\"a38b4480a698e812d\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_a38b4480a698e812d\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>A common finding during surveillance of multinational clinical trials by US sponsors or sponsors conducting a clinical trial under US regulations are FDA 1572 forms signed by investigators. FDA Form 1572 is rooted in US law <em>Title 21 Code of Federal Regulations (CRF) 312.53 (c) \u201cResponsibilities of Sponsors and Investigators: Selecting Investigators and monitors\u201d<\/em> and the form should be signed by the investigator if the CT is being conducted as a so-called IND study .<\/p>\n<p>In section 9 of FDA Form 1572, entitled &#8220;<em>Obligations<\/em>&#8220;, by signing the form the investigator agrees to comply with the following conditions, but not limited to:<\/p>\n<ul>\n<li><em>Title 21 CFR Part 50 (obtaining informed consent)<\/em><\/li>\n<li><em> Title 21 CFR Part 56 (ensuring that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for review and approval)<\/em><\/li>\n<li><em> Title 21 Part 312 (compliance with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements)<\/em><\/li>\n<li><em> Title 21 CFR 312.62 (maintaining adequate and accurate records, making these records available for inspections in accordance with 21 CFR 312.68)<\/em><\/li>\n<li><em> Title 21 CFR 312.64 (reporting of adverse experiences that occur in the course of the investigation)<\/em><\/li>\n<\/ul>\n<p>The above regulations are US regulations that are not valid in the RS.<\/p>\n<p>In accordance with FDA guidance 21 CFR 312.120 &#8211; the sponsor has the option to include sites that are not covered by the regulatory scope for IND studies as so-called non-IND sites. Thus, US requirements regarding the conduct of CTs will be met when the CT is conducted in accordance with international ethical standards and quality standards that are implemented in binding local requirements. In this case, the signing of FDA Form 1572 is not required.<\/p>\n<p>The question now is how to proceed when a signed FDA Form 1572 is found and\/or how to answer relevant legality questions.<\/p>\n<p>Clinical trials submitted to the US FDA for marketing approval must comply with the IND regulations found in <em>Title 21 CFR 312<\/em>. Compliance with it can be achieved by:<\/p>\n<ul>\n<li>conducting trials as IND or<\/li>\n<li>as a non-IND (&#8220;<em>non-IND foreign clinical study<\/em>&#8220;) or<\/li>\n<li>as a combination of investigational sites in the US as INDs and sites outside the US that are not under IND application (non-IND sites), whichever is most appropriate.<\/li>\n<\/ul>\n<p>If a sponsor chooses to submit a single protocol for an IND study and conduct a trial for all IND-designated study sites, then the sponsor and all investigators must meet all IND study requirements.<\/p>\n<p>If non-US local laws or regulations prohibit the signing of the FDA Form 1572, FDA should expect such sites to operate as non-IND sites or the trial conducted as a non-IND trial.<\/p>\n<p>If the sponsor decides to conduct a clinical trial without an IND and outside the USA, then the trial must be conducted in accordance with the regulation 21 CFR 312.120 &#8211; <em>Foreign clinical studies not conducted under an IND (Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions).<\/em><\/p>\n<p>If the sponsor chooses to conduct a multinational CT, with some sites outside the US, then the sponsor can choose not to have sites outside the US under the IND application.<\/p>\n<p>A sponsor may submit a single protocol to the FDA that clearly defines and describes both IND and non-IND sites. Investigators at these non-IND sites are not required to sign FDA Form 1572. However, the sponsor must ensure that the non-IND sites are in compliance with 21 CFR 312.120, &#8220;<em>Foreign clinical studies not conducted under an IND<\/em>,&#8221; \u200b\u200bwhich requires that the trial be conducted in in accordance with Good Clinical Practice (GCP) and that the FDA is able to validate data from on-site inspections, if deemed necessary by the FDA.<\/p>\n<p>A sponsor may submit one protocol for sites as IND (US sites and some foreign sites) and a separate protocol for foreign sites not under the IND definition. FDA Form 1572 does not apply to non-IND sites. If the intention is to pool data from US and foreign sites for marketing authorization, then the protocols would usually be very similar or identical. However, the FDA recommends that the sponsor discuss plans for pooling data from different sites with the appropriate FDA review division before starting the trial.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-52166d62d4409dffc fusion-toggle-has-divider\" style=\"--awb-title-color:var(--awb-color8);\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_52166d62d4409dffc\"><a aria-expanded=\"false\" aria-controls=\"52166d62d4409dffc\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-955-1\" data-target=\"#52166d62d4409dffc\" href=\"#52166d62d4409dffc\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box active-icon awb-icon-minus\" aria-hidden=\"true\"><\/i><i class=\"fa-fusion-box inactive-icon awb-icon-plus\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Conclusion<\/span><\/a><\/h4><\/div><div id=\"52166d62d4409dffc\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_52166d62d4409dffc\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>The signing of the FDA 1572 form by investigators in RS is unacceptable from the point of view of local regulations, because it gives assurance to the sponsor that the study will be conducted in accordance with the legal provisions of the USA, which is opposite with the requirements of the national regulations and even the EU regulations, because Serbia belongs to the countries of the European continent and harmonizes its work with EU guidelines.<\/p>\n<p>Therefore, it is desirable that sponsors include sites in RS as non-IND sites. If the sponsor, however, has decided to include sites in the RS as IND sites then the CT agreement with the investigator\/health institution should contain an explicit provision that national laws generally take precedence over US laws.<\/p>\n<p>In that case, the sponsor is expected to perform a comparative analysis that identifies discrepancies between local and US requirements and to demonstrate how compliance with applicable national regulations can be ensured.<\/p>\n<p>If FDA has granted a waiver at the sponsor&#8217;s request, it must be verified that the waiver covers all CFR requirements that are inconsistent with local requirements, such as IRB requirements, safety data reporting, data protection, retention periods, etc. The sponsor should explain CFR requirements to sites, particularly those requirements that conflict with or complementary to local legal requirements.<\/p>\n<p>The sponsor&#8217;s comparative analysis and the relevant FDA-approved waiver must be permanently attached to the FDA Form 1572 and stored in the Trial Master File (TMF) and the Investigator Site File (ISF) together with documents related to sponsor clarifications. If the waiver is approved, the sponsor should ask the investigator to file a copy of the letter approving the waiver at the ISF center. These documents must be submitted to the Agency upon request.<\/p>\n<p>A finding of a signed FDA Form 1572 without the above documents constitutes a Major finding for which the sponsor is responsible. The classification of the findings for which the investigator is responsible is based on the circumstances that arose during the supervision.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;width:100%;\"><div class=\"fusion-separator-border sep-double\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;border-bottom-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-2\"><p><strong><em><u>Special note:<\/u><\/em><\/strong><\/p>\n<ul>\n<li>recommendation to CRO companies and other sponsor representatives in Serbia to forward this Notice to their investigators<\/li>\n<li>this notice applies from the day it was published on the Agency&#8217;s website &#8211; it is not valid for cases that occurred before April 2025.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-955","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/comments?post=955"}],"version-history":[{"count":2,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/955\/revisions"}],"predecessor-version":[{"id":1005,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/955\/revisions\/1005"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}