
{"id":13195,"date":"2026-05-19T07:04:19","date_gmt":"2026-05-19T07:04:19","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/sscp-icinde-klinik-arastirmalar-ce-isareti-oncesi-nasil-sunulmalidir\/"},"modified":"2026-05-19T07:04:19","modified_gmt":"2026-05-19T07:04:19","slug":"sscp-icinde-klinik-arastirmalar-ce-isareti-oncesi-nasil-sunulmalidir","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/sscp-icinde-klinik-arastirmalar-ce-isareti-oncesi-nasil-sunulmalidir\/","title":{"rendered":"SSCP i\u00e7inde klinik ara\u015ft\u0131rmalar CE i\u015fareti \u00f6ncesi nas\u0131l sunulmal\u0131d\u0131r?"},"content":{"rendered":"<p>Klinik de\u011ferlendirme yaln\u0131zca literat\u00fcr listesi de\u011fildir; cihaz\u0131n ama\u00e7lanan kullan\u0131m\u0131n\u0131, klinik iddialar\u0131n\u0131, risklerini ve performans kan\u0131tlar\u0131n\u0131 bir araya getiren s\u00fcrekli bir s\u00fcre\u00e7tir. SSCP, hedef kullan\u0131c\u0131 ve hasta i\u00e7in anla\u015f\u0131l\u0131r \u015fekilde klinik veriyi, fayda-risk sonucunu ve ara\u015ft\u0131rma durumunu \u00f6zetlemelidir. \u00dcretici, kullan\u0131lan verinin kalitesini, veri kayna\u011f\u0131na eri\u015fimi, e\u015fde\u011ferlik gerek\u00e7esini ve PMS\/PMCF \u00e7\u0131kt\u0131lar\u0131n\u0131n CER \u00fczerindeki etkisini a\u00e7\u0131k\u00e7a yazmal\u0131d\u0131r. Sonu\u00e7 b\u00f6l\u00fcm\u00fcnde klinik fayda-risk kabul\u00fc \u00fcr\u00fcn \u00f6zelinde gerek\u00e7elendirilmelidir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Klinik de\u011ferlendirme yaln\u0131zca literat\u00fcr listesi de\u011fildir; cihaz\u0131n ama\u00e7lanan kullan\u0131m\u0131n\u0131, klinik iddialar\u0131n\u0131, risklerini ve performans kan\u0131tlar\u0131n\u0131 bir araya getiren s\u00fcrekli bir [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"kkqa_category":[455],"kkqa_letter":[467],"class_list":["post-13195","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-klinik-degerlendirme","kkqa_letter-c"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13195","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13195"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13195\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13195"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13195"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13195"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}