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25					<meta name="description" content="Clinical Research Organization
26ELOT EN ISO 9001: 2015
27 
28CRO registration number: 158-C-23    
29Regulatory affairs
30 Drafting of protocols and of consent forms.
31 Education of all principal investigators"/>
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36		<meta property="og:title" content="  Clinical Research Organization"/>
37				<meta property="og:description" content="Clinical Research Organization
38ELOT EN ISO 9001: 2015
39 
40CRO registration number: 158-C-23    
41Regulatory affairs
42 Drafting of protocols and of consent forms.
43 Education of all principal investigators"/>
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214			<span class="entry-title rich-snippet-hidden">Clinical Research Organization</span><span class="vcard rich-snippet-hidden"><span class="fn"><a href="https://sepsis.gr/author/hiss/" rel="author">hiss</a></span></span><span class="updated rich-snippet-hidden">2023-12-27T11:36:52+03:00</span>
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217				<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:1289.6px;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_1 1_1 fusion-flex-column" style="--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--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"><h3 style="text-align: center;" data-fontsize="30" data-lineheight="36px">Clinical Research Organization</h3>
218<h3 class="fusion-responsive-typography-calculated" style="text-align: center;" data-fontsize="30" data-lineheight="36px">ELOT EN ISO 9001: 2015</h3>
219<h4 style="text-align: center;"></h4>
220</div><div class="fusion-text fusion-text-2"><h4 style="text-align: center; color: #6f9fbc; font-weight: bold;" data-fontsize="30" data-lineheight="36px">CRO registration number: 158-C-23</h4>
221</div></div></div></div></div><div class="fusion-fullwidth fullwidth-box fusion-builder-row-2 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:1289.6px;margin-left: calc(-4% / 2 );margin-right: calc(-4% / 2 );"><div class="fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_2 1_2 fusion-flex-column" style="--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--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-3"><h5 class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px">Regulatory affairs</h5>
222<p class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-1 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Drafting of protocols and of consent forms.</p>
223<p data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-2 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Education of all principal investigators and sub-investigators for Good Clinical Practice.</p>
224<p data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-3 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Registration for EudraCT number and EudraCT protocol registration.</p>
225<p data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-4 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Coordination of submission to all study sites and central regulatory submission, for countries where this is needed.</p>
226<p data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-5 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Correspondence with regulatory bodies and protocol amendments.</p>
227<p data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-6 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Correspondence for requested amendments of submission files.</p>
228<p data-fontsize="32" data-lineheight="40px"><i class="fb-icon-element-7 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>
228Registration at ClinicalTrials.gov after study protocol approval GCP certification.</p>
229</div><div class="fusion-text fusion-text-4"><h5 class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px">Financial affairs</h5>
230</div><div class="fusion-text fusion-text-5"><h5 class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px">Auditing service</h5>
231</div></div></div><div class="fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_2 1_2 fusion-flex-column" style="--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--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-6"><h5 class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px">Safety Monitoring</h5>
232<p><i class="fb-icon-element-8 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Pharmacovigilance</p>
233<p><i class="fb-icon-element-9 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Coordination of Safety Monitoring Board</p>
234</div><div class="fusion-text fusion-text-7"><h5 class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px">Monitoring of clinical data, lab data and lab samples</h5>
235<p><i class="fb-icon-element-10 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Coordination of blinded and un-blinded clinical research associates (CRAs) for study monitoring</p>
236<p><i class="fb-icon-element-11 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Interaction with Data Monitoring Committees</p>
237</div><div class="fusion-text fusion-text-8"><h5 class="fusion-responsive-typography-calculated" data-fontsize="32" data-lineheight="40px">Data handling</h5>
238<p><i class="fb-icon-element-12 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Available study <a href="https://sepsis.gr/studies/">portal</a></p>
239<p><i class="fb-icon-element-13 fb-icon-element fontawesome-icon fa-check-square far circle-no fusion-text-flow" style="--awb-iconcolor:#6f9fbc;--awb-iconcolor-hover:#6f9fbc;--awb-font-size:14px;--awb-margin-right:7px;"></i>Maintenance of database</p>
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259<p style="font-size: 12px; line-height: 18px; font-weight: 300; text-align: left;">The Hellenic Institute for the Study of Sepsis (HISS) is a leading, non-
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267href=" https://sepsis.gr/gender-equality-plan">Gender Equality Plan (GEP)</a></p
268<div style="clear:both;"></div></section>																					</div>
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271<p style="font-size: 12px; color: #eae9e9; line-height: 18px; font-weight: 300; text-align: left;"><a href="https://sepsis.gr/executive-board/">Evangelos J. Giamarellos-Bourboulis, MD, PhD, FISAC <br/>Professor of Internal Medicine and Infectious Diseases</a></p><div style="clear:both;"></div></section>																					</div>
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274<p style="font-size: 12px; line-height: 18px; font-weight: 300; text-align: left;">
275+30-210-7480662</br>
276[email protected]</br>
27717 Laodikias</br> 
27811528 Athens</br>
279Greece</p><div style="clear:both;"></div></section>																					</div>
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440//# sourceURL=avada-drop-down-js-extra
441</script>
vendor: 1 bytes, line 441
441
442<script id="avada-drop-down-js" src="https://sepsis.gr/wp-content/themes/Avada/assets/min/js/general/avada-drop-down.js?ver=7.16.1"></script>
vendor: 1 bytes, line 442
442
443<script id="avada-to-top-js-extra">
444var avadaToTopVars = {"status_totop":"desktop_and_mobile","totop_position":"right","totop_scroll_down_only":"1"};
445//# sourceURL=avada-to-top-js-extra
446</script>
vendor: 1 bytes, line 446
446
447<script id="avada-to-top-js" src="https://sepsis.gr/wp-content/themes/Avada/assets/min/js/general/avada-to-top.js?ver=7.16.1"></script>
vendor: 1 bytes, line 447
447
448<script id="avada-header-js-extra">
449var avadaHeaderVars = {"header_position":"top","header_sticky":"1","header_sticky_type2_layout":"menu_only","header_sticky_shadow":"1","side_header_break_point":"1099","header_sticky_mobile":"","header_sticky_tablet":"","mobile_menu_design":"classic","sticky_header_shrinkage":"","nav_height":"85","nav_highlight_border":"0","nav_highlight_style":"textcolor","logo_margin_top":"2px","logo_margin_bottom":"2px","layout_mode":"wide","header_padding_top":"0px","header_padding_bottom":"0px","scroll_offset":"full"};
450//# sourceURL=avada-header-js-extra
451</script>
vendor: 1 bytes, line 451
451
452<script id="avada-header-js" src="https://sepsis.gr/wp-content/themes/Avada/assets/min/js/general/avada-header.js?ver=7.16.1"></script>
vendor: 1 bytes, line 452
452
453<script id="avada-menu-js-extra">
454var avadaMenuVars = {"site_layout":"wide","header_position":"top","logo_alignment":"left","header_sticky":"1","header_sticky_mobile":"","header_sticky_tablet":"","side_header_break_point":"1099","megamenu_base_width":"custom_width","mobile_menu_design":"classic","dropdown_goto":"Go to...","mobile_nav_cart":"Shopping Cart","mobile_submenu_open":"Open submenu of %s","mobile_submenu_close":"Close submenu of %s","submenu_slideout":"1"};
455//# sourceURL=avada-menu-js-extra
456</script>
vendor: 1 bytes, line 456
456
457<script id="avada-menu-js" src="https://sepsis.gr/wp-content/themes/Avada/assets/min/js/general/avada-menu.js?ver=7.16.1"></script>
vendor: 1 bytes, line 457
457
458<script id="awb-scrollspy-js" src="https://sepsis.gr/wp-content/themes/Avada/assets/min/js/library/awb-scrollspy.js?ver=7.16.1"></script>
vendor: 1 bytes, line 458
458
459<script id="avada-scrollspy-js" src="https://sepsis.gr/wp-content/themes/Avada/assets/min/js/general/avada-scrollspy.js?ver=7.16.1"></script>
vendor: 1 bytes, line 459
459
460<script id="fusion-responsive-typography-js-extra">
461var fusionTypographyVars = {"site_width":"1240px","typography_sensitivity":"0.54","typography_factor":"1.50","elements":"h1, h2, h3, h4, h5, h6"};
462//# sourceURL=fusion-responsive-typography-js-extra
463</script>
vendor: 1 bytes, line 463
463
464<script id="fusion-responsive-typography-js" src="https://sepsis.gr/wp-content/themes/Avada/includes/lib/assets/min/js/general/fusion-responsive-typography.js?ver=3.16.1"></script>
vendor: 1 bytes, line 464
464
465<script id="fusion-scroll-to-anchor-js-extra">
466var fusionScrollToAnchorVars = {"content_break_point":"800","container_hundred_percent_height_mobile":"0"};
467//# sourceURL=fusion-scroll-to-anchor-js-extra
468</script>
vendor: 1 bytes, line 468
468
469<script id="fusion-scroll-to-anchor-js" src="https://sepsis.gr/wp-content/themes/Avada/includes/lib/assets/min/js/general/fusion-scroll-to-anchor.js?ver=3.16.1"></script>
vendor: 1 bytes, line 469
469
470<script id="fusion-video-js-extra">
471var fusionVideoVars = {"status_vimeo":"1"};
472//# sourceURL=fusion-video-js-extra
473</script>
vendor: 1 bytes, line 473
473
474<script id="fusion-video-js" src="https://sepsis.gr/wp-content/plugins/fusion-builder/assets/js/min/general/fusion-video.js?ver=3.16.1"></script>
vendor: 1 bytes, line 474
474
475<script id="fusion-column-js" src="https://sepsis.gr/wp-content/plugins/fusion-builder/assets/js/min/general/fusion-column.js?ver=3.16.1"></script>
vendor: 1 bytes, line 475
475
476<script id="wp-emoji-settings" type="application/json">
477{"baseUrl":"https://s.w.org/images/core/emoji/17.0.2/72x72/","ext":".png","svgUrl":"https://s.w.org/images/core/emoji/17.0.2/svg/","svgExt":".svg","source":{"concatemoji":"https://sepsis.gr/wp-includes/js/wp-emoji-release.min.js?ver=7.0.6"}}
478</script>
vendor: 1 bytes, line 478
478
479<script type="module">
480/*! This file is auto-generated */
481var e="script#wp-emoji-settings",t=document.querySelector(e);if(!(t instanceof HTMLScriptElement))throw new Error("Element missing: "+e);const r=JSON.parse(t.text),s=(window._wpemojiSettings=r,"wpEmojiSettingsSupports"),o=["flag","emoji"];function i(e){try{var t={supportTests:e,timestamp:(new Date).valueOf()};sessionStorage.setItem(s,JSON.stringify(t))}catch(e){}}function c(e,t,n){e.clearRect(0,0,e.canvas.width,e.canvas.height),e.fillText(t,0,0);t=new Uint32Array(e.getImageData(0,0,e.canvas.width,e.canvas.height).data);e.clearRect(0,0,e.canvas.width,e.canvas.height),e.fillText(n,0,0);const r=new Uint32Array(e.getImageData(0,0,e.canvas.width,e.canvas.height).data);return t.every((e,t)=>e===r[t])}function p(e,t){e.clearRect(0,0,e.canvas.width,e.canvas.height),e.fillText(t,0,0);var n=e.getImageData(16,16,1,1);for(let e=0;e<n.data.length;e++)if(0!==n.data[e])return!1;return!0}function u(e,t,n,r){switch(t){case"flag":return n(e,"\ud83c\udff3\ufe0f\u200d\u26a7\ufe0f","\ud83c\udff3\ufe0f\u200b\u26a7\ufe0f")?!1:!n(e,"\ud83c\udde8\ud83c\uddf6","\ud83c\udde8\u200b\ud83c\uddf6")&&!n(e,"\ud83c\udff4\udb40\udc67\udb40\udc62\udb40\udc65\udb40\udc6e\udb40\udc67\udb40\udc7f","\ud83c\udff4\u200b\udb40\udc67\u200b\udb40\udc62\u200b\udb40\udc65\u200b\udb40\udc6e\u200b\udb40\udc67\u200b\udb40\udc7f");case"emoji":return!r(e,"\ud83e\u1fac8")}return!1}function f(e,t,n,r){let a;const s=(a="undefined"!=typeof WorkerGlobalScope&&self instanceof WorkerGlobalScope?new OffscreenCanvas(300,150):document.createElement("canvas")).getContext("2d",{willReadFrequently:!0}),o=(s.textBaseline="top",s.font="600 32px Arial",{});return e.forEach(e=>{o[e]=t(s,e,n,r)}),o}function a(e){var t=document.createElement("script");t.src=e,t.defer=!0,document.head.appendChild(t)}r.supports={everything:!0,everythingExceptFlag:!0},new Promise(t=>{let n=function(){try{var e=JSON.parse(sessionStorage.getItem(s));if("object"==typeof e&&"number"==typeof e.timestamp&&(new Date).valueOf()<e.timestamp+604800&&"object"==typeof e.supportTests)return e.supportTests}catch(e){}return null}();if(!n){if("undefined"!=typeof Worker&&"undefined"!=typeof OffscreenCanvas&&"undefined"!=typeof URL&&URL.createObjectURL&&"undefined"!=typeof Blob)try{var e="postMessage("+f.toString()+"("+[JSON.stringify(o),u.toString(),c.toString(),p.toString()].join(",")+"));",r=new Blob([e],{type:"text/javascript"});const a=new Worker(URL.createObjectURL(r),{name:"wpTestEmojiSupports"});return void(a.onmessage=e=>{i(n=e.data),a.terminate(),t(n)})}catch(e){}i(n=f(o,u,c,p))}t(n)}).then(e=>{for(const n in e)r.supports[n]=e[n],r.supports.everything=r.supports.everything&&r.supports[n],"flag"!==n&&(r.supports.everythingExceptFlag=r.supports.everythingExceptFlag&&r.supports[n]);var t;r.supports.everythingExceptFlag=r.supports.everythingExceptFlag&&!r.supports.flag,r.supports.everything||((t=r.source||{}).concatemoji?a(t.concatemoji):t.wpemoji&&t.twemoji&&(a(t.twemoji),a(t.wpemoji)))});
482//# sourceURL=https://sepsis.gr/wp-includes/js/wp-emoji-loader.min.js
483</script>
483
484				
484<script type="text/javascript">
485				jQuery( document ).ready( function() {
486					var ajaxurl = 'https://sepsis.gr/wp-admin/admin-ajax.php';
487					if ( 0 < jQuery( '.fusion-login-nonce' ).length ) {
488						jQuery.get( ajaxurl, { 'action': 'fusion_login_nonce' }, function( response ) {
489							jQuery( '.fusion-login-nonce' ).html( response );
490						});
491					}
492				});
493				</script>
493
494						</div>
495
496			<section class="to-top-container to-top-right" aria-labelledby="awb-to-top-label">
497		<a href="#" id="toTop" class="fusion-top-top-link">
498			<span id="awb-to-top-label" class="screen-reader-text">Go to Top</span>
499
500					</a>
501	</section>
502		</body>
503</html>

Line numbers count LF bytes from the start of the resource, as the search results do. Vendor segments are library code the classifier recognised; they are stored but not indexed. Bytes are shown as Latin1 characters, one per byte.