{"id":953,"date":"2025-04-29T07:27:15","date_gmt":"2025-04-29T06:27:15","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=953"},"modified":"2025-05-19T09:03:26","modified_gmt":"2025-05-19T08:03:26","slug":"gcp-metrics","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/gcp-metrics\/","title":{"rendered":"GCP Metrics"},"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 class=\"awb-menu awb-menu_column awb-menu_em-hover 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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;\">GCP Metrics<\/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-953-1\"><div class=\"fusion-panel panel-default panel-4532d38da6583d4ad fusion-toggle-has-divider\" style=\"--awb-title-color:var(--awb-color8);\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_4532d38da6583d4ad\"><a aria-expanded=\"false\" aria-controls=\"4532d38da6583d4ad\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-953-1\" data-target=\"#4532d38da6583d4ad\" href=\"#4532d38da6583d4ad\"><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\">GCP Metrics 2022<\/span><\/a><\/h4><\/div><div id=\"4532d38da6583d4ad\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_4532d38da6583d4ad\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>During 2022, 17 GCP supervisions of clinical trials were implemented in the same number of healthcare institutions\/investigational sites.<\/p>\n<ul>\n<li>Defined KPI for 2022 in Agency: Number of planned GCP supervisions in the current year \u2013 at least 12<\/li>\n<\/ul>\n<p>Implementation: &gt;100%<\/p>\n<p>All GCP supervisions implemented in 2022 are routine supervisions of trial site (investigational sites) in healthcare institutions, and were conducted remotely due to the conditions of the COVID 19 pandemic. The Agency conducts supervisions in accordance with local regulations, international regulations and its own procedures. During the supervisions, data integrity and patient safety of subjects in clinical trials are checked.<\/p>\n<p><strong><u>Categorisation of the findings<\/u><\/strong><\/p>\n<ol>\n<li><strong><em>A) General Overview<\/em><\/strong><\/li>\n<\/ol>\n<p>A total of 169 findings were identified across the 17 sites supervised, including 27 Critical findings, 32 Major findings, 110 Minor findings and 62 Opservations. This represents an average of 10 findings per site supervised. The main findings observed in 2022 are detailed below in accordance with the GCP findings categorisation.<\/p>\n<p><strong><em>Table 1. Number of findings &#8211; Critical, Major, Minor<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1029\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082139-300x91.png\" alt=\"\" width=\"300\" height=\"91\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082139-200x61.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082139-300x91.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082139.png 380w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 1. Number of findings &#8211; Critical, Major, Minor<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1016\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081014-300x181.png\" alt=\"\" width=\"300\" height=\"181\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081014-200x121.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081014-300x181.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081014-400x241.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081014.png 482w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>b) Distribution by category<\/em><\/strong><\/p>\n<p><strong><em>Table 2: Number of findings by main categories and severity of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1017\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081146-300x183.png\" alt=\"\" width=\"300\" height=\"183\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081146-200x122.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081146-300x183.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081146-400x244.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081146.png 434w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 2: Number of findings by main categories and severity of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1018\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081243-300x179.png\" alt=\"\" width=\"300\" height=\"179\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081243-200x119.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081243-300x179.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081243-400x239.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081243.png 483w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>c) Distribution by sub-categorie<\/em><\/strong><\/p>\n<p><strong><em>Table 3: Number of findings by sub-categories and by degree of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1019\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081353-300x278.png\" alt=\"\" width=\"300\" height=\"278\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081353-200x186.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081353-300x278.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081353-400x371.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081353.png 497w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 3: Number of findings by sub-categories and by degree of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1020\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081444-300x248.png\" alt=\"\" width=\"300\" height=\"248\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081444-200x165.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081444-300x248.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081444-400x330.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081444-600x495.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081444.png 625w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Finally, Table 4 shows the distribution of responsibilities for each grading of finding.<\/em><\/strong><\/p>\n<p><strong><em>Table 4: Responsibility for findings, Summary<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1021\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081535-300x70.png\" alt=\"\" width=\"300\" height=\"70\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081535-200x47.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081535-300x70.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081535-400x94.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081535-600x141.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081535.png 626w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 5. Investigator&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1022\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081620-300x91.png\" alt=\"\" width=\"300\" height=\"91\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081620-200x61.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081620-300x91.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081620.png 364w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure <\/em><\/strong><strong><em>4. Investigator&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1023\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081710-300x181.png\" alt=\"\" width=\"300\" height=\"181\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081710-200x121.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081710-300x181.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081710-400x242.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081710.png 483w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 6. Sponsor&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1024\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081810-300x231.png\" alt=\"\" width=\"300\" height=\"231\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081810-200x154.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081810-300x231.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081810-400x308.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081810.png 408w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 5. Sponsor&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1025\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081851-300x149.png\" alt=\"\" width=\"300\" height=\"149\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081851-200x100.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081851-300x149.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081851-400x199.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081851.png 586w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 7. Findings regarding shared responsibility between sponsors and investigators<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1026\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081935-300x278.png\" alt=\"\" width=\"300\" height=\"278\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081935-200x186.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081935-300x278.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081935-400x371.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-081935.png 445w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 6. Findings regarding shared responsibility between sponsors and investigators<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1027\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082018-300x201.png\" alt=\"\" width=\"300\" height=\"201\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082018-200x134.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082018-300x201.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082018-400x268.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082018-600x403.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-082018.png 614w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-9eadc38c69416e8fb fusion-toggle-has-divider\" style=\"--awb-title-color:var(--awb-color8);\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_9eadc38c69416e8fb\"><a aria-expanded=\"false\" aria-controls=\"9eadc38c69416e8fb\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-953-1\" data-target=\"#9eadc38c69416e8fb\" href=\"#9eadc38c69416e8fb\"><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\">GCP Metrics 2023<\/span><\/a><\/h4><\/div><div id=\"9eadc38c69416e8fb\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_9eadc38c69416e8fb\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>During 2023, 22 GCP supervisions of clinical trials were implemented in the same number of healthcare institutions\/investigational sites.<\/p>\n<ul>\n<li>Defined KPI for 2023 in Agency: Number of planned GCP supervisions in the current year \u2013 at least 20<\/li>\n<\/ul>\n<p>Implementation: &gt;100%<\/p>\n<p>All GCP supervisions implemented in 2023 are supervisions of trial site (investigational sites) in healthcare institutions.\u00a0 During the first quarter of 2023, due to the conditions of the COVID19 pandemic, 6 GCP supervisions were conducted &#8220;<em>remotely<\/em>&#8220;, the remaining 16 were conducted in (at investigational sites) in healthcare institutions. The Agency conducts supervisions in accordance with local regulations, international regulations and its own procedures. During the supervision, data integrity and patient safety of subjects in clinical trials are checked.<\/p>\n<p>Of the total of 22 GCP supervisions conducted, 20 were routine and 2 were triggered by the Agency&#8217;s Clinical Trials Department.<\/p>\n<ol>\n<li><strong><em>A) General Overview<\/em><\/strong><\/li>\n<\/ol>\n<p>A total of 124 findings were identified across the 22 sites supervised, including 12 Critical findings, 25 Major findings, 87 Minor findings and 32 Opservations. This represents an average of 6 findings per site inspected. The main findings observed in 2023 are detailed below in accordance with the GCP findings categorisation.<\/p>\n<p><strong><em>Table 1. Number of findings &#8211; Critical, Major, Minor<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1032\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092741-300x89.png\" alt=\"\" width=\"300\" height=\"89\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092741-200x59.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092741-300x89.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092741.png 381w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 1. Number of findings &#8211; Critical, Major, Minor<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1033\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092825-300x170.png\" alt=\"\" width=\"300\" height=\"170\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092825-200x114.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092825-300x170.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092825-400x227.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092825.png 505w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>b) Distribution by category<\/em><\/strong><\/p>\n<p><strong><em>Table 2: Number of findings by main categories and severity of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1034\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092919-300x182.png\" alt=\"\" width=\"300\" height=\"182\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092919-200x121.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092919-300x182.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092919-400x243.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-092919.png 438w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 2: Number of findings by main categories and severity of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1035\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093005-300x181.png\" alt=\"\" width=\"300\" height=\"181\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093005-200x120.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093005-300x181.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093005-400x241.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093005.png 483w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>c) Distribution by sub-categories<\/em><\/strong><\/p>\n<p><strong><em>Table 3: Number of findings by sub-categories and by degree of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1037\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093225-248x300.png\" alt=\"\" width=\"248\" height=\"300\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093225-200x242.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093225-248x300.png 248w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093225-400x484.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093225.png 498w\" sizes=\"(max-width: 248px) 100vw, 248px\" \/><\/p>\n<p><strong><em>Figure 3: Number of findings by sub-categories and by degree of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1038\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093314-300x233.png\" alt=\"\" width=\"300\" height=\"233\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093314-200x156.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093314-300x233.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093314-400x311.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093314-600x467.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093314.png 626w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Finally, Table 4 shows the distribution of responsibilities for each grading of finding.<\/em><\/strong><\/p>\n<p><strong><em>Table 4: Responsibility for findings, Summary<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1039\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093421-300x70.png\" alt=\"\" width=\"300\" height=\"70\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093421-200x47.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093421-300x70.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093421-400x94.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093421-600x141.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093421.png 626w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 5. Investigator&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1040\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093515-300x106.png\" alt=\"\" width=\"300\" height=\"106\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093515-200x70.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093515-300x106.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093515.png 366w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure <\/em><\/strong><strong><em>4. Investigator&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1041\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093557-300x181.png\" alt=\"\" width=\"300\" height=\"181\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093557-200x121.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093557-300x181.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093557-400x241.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093557.png 482w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 6. Sponsor&#8217;s responsibility regarding sub-category findings\u017e<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1042\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093708-300x231.png\" alt=\"\" width=\"300\" height=\"231\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093708-200x154.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093708-300x231.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093708-400x308.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093708.png 408w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 5. Sponsor&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1043\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093758-300x163.png\" alt=\"\" width=\"300\" height=\"163\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093758-200x108.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093758-300x163.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093758-400x217.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093758.png 594w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 7. Findings regarding shared responsibility between sponsors and investigators<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1044\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093850-300x255.png\" alt=\"\" width=\"300\" height=\"255\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093850-200x170.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093850-300x255.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093850-400x340.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093850.png 444w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 6. Findings regarding shared responsibility between sponsors and investigators<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1045\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093936-300x207.png\" alt=\"\" width=\"300\" height=\"207\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093936-200x138.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093936-300x207.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093936-400x276.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-093936.png 553w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default panel-912dd033338da1d98 fusion-toggle-has-divider\" style=\"--awb-title-color:var(--awb-color8);\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\" id=\"toggle_912dd033338da1d98\"><a aria-expanded=\"false\" aria-controls=\"912dd033338da1d98\" role=\"button\" data-toggle=\"collapse\" data-parent=\"#accordion-953-1\" data-target=\"#912dd033338da1d98\" href=\"#912dd033338da1d98\"><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\">GCP Metrics 2024<\/span><\/a><\/h4><\/div><div id=\"912dd033338da1d98\" class=\"panel-collapse collapse \" aria-labelledby=\"toggle_912dd033338da1d98\"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>During 2024, 19 GCP supervisions of clinical trials were implemented in the same number of healthcare institutions\/investigational sites.<\/p>\n<ul>\n<li>Defined KPI for 2024 in Agency: Number of planned GCP supervisions in the current year \u2013 at least 20<\/li>\n<\/ul>\n<p>Implementation: 95% achieved<\/p>\n<p>All GCP supervisions implemented in 2024 are supervision of trial site (investigational sites) in healthcare institutions. The Agency conducts supervision in accordance with local regulations, international regulations and its own procedures. During the GCP supervision, data integrity and patient safety of subjects in clinical trials are checked.<\/p>\n<p><strong><u>Categorisation of findings<\/u><\/strong><\/p>\n<ol>\n<li><strong><em>A) General Overview<\/em><\/strong><\/li>\n<\/ol>\n<p>A total of 93 findings were identified across the 19 sites supervised, including 8 Major findings, 85 Minor findings and 29 Observations. This represents an average of 5 findings per site supervised. The main findings observed in 2024 are detailed below in accordance with the GCP findings categorisation.<\/p>\n<p><strong><em>Table 1. Number of findings &#8211; Critical, Major, Minor<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1046\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094256-300x84.png\" alt=\"\" width=\"300\" height=\"84\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094256-200x56.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094256-300x84.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094256.png 381w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 1. Number of findings &#8211; Critical, Major, Minor<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1047\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094337-300x181.png\" alt=\"\" width=\"300\" height=\"181\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094337-200x121.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094337-300x181.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094337-400x242.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094337.png 483w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>b) Distribution by category<\/em><\/strong><\/p>\n<p><strong><em>Table 2: Number of findings by main categories and severity of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1048\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094427-300x183.png\" alt=\"\" width=\"300\" height=\"183\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094427-200x122.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094427-300x183.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094427-400x245.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094427.png 440w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 2: Number of findings by main categories and severity of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1049\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094514-300x181.png\" alt=\"\" width=\"300\" height=\"181\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094514-200x121.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094514-300x181.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094514-400x241.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-094514.png 484w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>c) Distribution by sub-categories<\/em><\/strong><\/p>\n<p><strong><em>Table 3: Number of findings by sub-categories and by degree of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1050\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095459-300x240.png\" alt=\"\" width=\"300\" height=\"240\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095459-177x142.png 177w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095459-200x160.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095459-300x240.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095459-400x320.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095459.png 498w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 3: Number of findings by sub-categories and by degree of findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1051\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095556-300x174.png\" alt=\"\" width=\"300\" height=\"174\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095556-200x116.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095556-300x174.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095556-400x232.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095556-600x348.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095556.png 625w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Finally, Table 4 shows the distribution of responsibilities for each grading of finding.<\/em><\/strong><\/p>\n<p><strong><em>Table 4: Responsibility of findings, Summary<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1052\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095641-300x67.png\" alt=\"\" width=\"300\" height=\"67\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095641-200x44.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095641-300x67.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095641-400x89.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095641-600x133.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095641.png 627w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 5. Investigator&#8217;s responsibility regarding sub-category findings <\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1054\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095722-300x122.png\" alt=\"\" width=\"300\" height=\"122\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095722-200x81.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095722-300x122.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095722.png 365w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 5. Investigator&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1055\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095831-300x158.png\" alt=\"\" width=\"300\" height=\"158\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095831-200x105.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095831-300x158.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095831-400x210.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095831.png 559w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 6. Sponsor&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1056\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095917-300x185.png\" alt=\"\" width=\"300\" height=\"185\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095917-200x123.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095917-300x185.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095917-400x246.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-095917.png 413w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 5. Sponsor&#8217;s responsibility regarding sub-category findings<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1057\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118-300x122.png\" alt=\"\" width=\"300\" height=\"122\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118-200x81.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118-300x122.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118-400x163.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118-600x244.png 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118-669x272.png 669w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100118.png 716w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Table 7. Findings regarding shared responsibility between sponsors and investigators<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1058\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100218-300x173.png\" alt=\"\" width=\"300\" height=\"173\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100218-200x115.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100218-300x173.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100218-400x230.png 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100218.png 436w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p><strong><em>Figure 6. Findings regarding shared responsibility between sponsors and investigators<\/em><\/strong><\/p>\n<p><img decoding=\"async\" class=\"alignnone size-medium wp-image-1059\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100300-300x183.png\" alt=\"\" width=\"300\" height=\"183\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100300-200x122.png 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100300-300x183.png 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2025\/05\/Screenshot-2025-05-19-100300.png 400w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<\/div><\/div><\/div><\/div><\/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-953","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/953","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=953"}],"version-history":[{"count":6,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/953\/revisions"}],"predecessor-version":[{"id":1060,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/953\/revisions\/1060"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=953"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}