{"id":16083,"date":"2020-04-22T12:23:20","date_gmt":"2020-04-22T12:23:20","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=16083"},"modified":"2022-06-09T13:01:14","modified_gmt":"2022-06-09T13:01:14","slug":"klinik-arastirmalarda-uygulanacak-covid-19-tedbirleri-hakkinda-sikca-sorulan-sorular-dokumani-yayimlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2020\/04\/22\/klinik-arastirmalarda-uygulanacak-covid-19-tedbirleri-hakkinda-sikca-sorulan-sorular-dokumani-yayimlandi\/","title":{"rendered":"Klinik Ara\u015ft\u0131rmalarda Uygulanacak COVID-19 Tedbirleri Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular Dok\u00fcman\u0131 Yay\u0131mland\u0131"},"content":{"rendered":"<p><strong>Yeni Geli\u015fmeler<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>Kurum<\/strong>&#8220;), 20 Nisan 2020 tarihinde yapt\u0131\u011f\u0131 duyuruda COVID-19 pandemisi nedeniyle klinik ara\u015ft\u0131rmalarda al\u0131nacak tedbirler hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular (SSS) dok\u00fcman\u0131n\u0131 yay\u0131mlad\u0131. Dok\u00fcmana <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=TVQybGEwY2U3ZW1YcHpsaVhrZDRrV1BqQkxZWnhFRFVudS90SWNxckVFdlBzYVpTb214b2ExbVNlSW52OFdvcTM3SzFTVmg0VUFKQnJnYkc4TVU5eitjWkF6b3Qvb29IVTNIWmVVMWxtTk4yTGI4S05UY0pWV1VTa0xGaktjaTRHRXMvaGR5Z0JEQk5KRjhnNjBxcWM2eEhqT1hOSFRQODM1RnBlTmJmUGRyVTlmY3Y4cEsvM2xXZ0RiRUNXZ2hU&amp;rh=ff005f7c7ba5a82a7dc6a1e0334c835c1fd096cc__;!!Hj9Y_P0nvg!Dzpb_4mWRwEjHepI_xdmBu3y8zSxDGGPpdMOro5dRynQFNAE-_MjCq1tlZbzXlkw3wJZEw$\">buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz.<\/p>\n<p><strong>Dok\u00fcman Ne Diyor?<\/strong><\/p>\n<p>SSS Dok\u00fcman\u0131, Kurum&#8217;un COVID-19 s\u00fcrecinde klinik ara\u015ft\u0131rmalar hakk\u0131nda ald\u0131\u011f\u0131 sorular do\u011frultusunda haz\u0131rland\u0131. Kurum&#8217;un a\u00e7\u0131klamalar\u0131 uyar\u0131nca g\u00f6n\u00fcll\u00fclerin g\u00fcvenli\u011fini etkileyebilecek yeni bir durumun ortaya \u00e7\u0131kmas\u0131 halinde, destekleyiciler ve sorumlu ara\u015ft\u0131rmac\u0131lar Kurum&#8217;dan veya etik kuruldan onay almaks\u0131z\u0131n g\u00f6n\u00fcll\u00fc al\u0131m\u0131 durdurma gibi acil g\u00fcvenlik \u00f6nlemleri alabilecek.<\/p>\n<p>Kurum, COVID-19 s\u00fcrecinde uzaktan izleme faaliyeti kapsam\u0131nda uzaktan kaynak dok\u00fcmantasyon de\u011ferlendirme s\u00fcre\u00e7lerinin Ki\u015fisel Verilerin Korunmas\u0131 Kanunu ve ikincil mevzuata uygun \u015fekilde y\u00fcr\u00fct\u00fclmesi, bu hususta g\u00f6n\u00fcll\u00fclerden olur al\u0131nmas\u0131 ve ki\u015fisel verilerin korunmas\u0131 a\u00e7\u0131s\u0131ndan gerekli idari ve teknik \u00f6nlemlerin al\u0131nmas\u0131 gerekti\u011fini belirtti.<\/p>\n<p>COVID-19 tedbirleri kapsam\u0131nda sa\u011fl\u0131k personeli taraf\u0131ndan uygulanmas\u0131 gerekmeyen ara\u015ft\u0131rma \u00fcr\u00fcnleri, do\u011frudan g\u00f6n\u00fcll\u00fcn\u00fcn belirleyece\u011fi lokasyona transfer edilebilecek. Bu hususta destekleyiciler, \u0130yi Da\u011f\u0131t\u0131m Uygulamalar\u0131na uygun \u00e7al\u0131\u015fan \u00fc\u00e7\u00fcnc\u00fc taraf bir hizmet sa\u011flay\u0131c\u0131dan (lojistik firmas\u0131) destek alabilecek.<\/p>\n<p>Klinik ara\u015ft\u0131rma kapsam\u0131ndaki g\u00f6n\u00fcll\u00fc vizitleri, g\u00f6n\u00fcll\u00fcn\u00fcn evi veya di\u011fer ara\u015ft\u0131rma merkez ya da sa\u011fl\u0131k kurulu\u015fu gibi g\u00f6n\u00fcll\u00fc ve ara\u015ft\u0131rma ekibinin mutab\u0131k kald\u0131\u011f\u0131 bir lokasyonda ger\u00e7ekle\u015ftirilebilecek.<\/p>\n<p>\u0130nsani ama\u00e7l\u0131 erken eri\u015fim programlar\u0131 kapsam\u0131nda yap\u0131lacak i\u015flemler, s\u00f6z konusu SSS dok\u00fcman\u0131 kapsam\u0131nda de\u011ferlendirilmeyecek. Bu hususta Kurum&#8217;un ilgili daire ba\u015fkanl\u0131\u011f\u0131 ile irtibata ge\u00e7ilmesi gerekecek.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum, COVID-19 salg\u0131n\u0131n\u0131n \u00f6nlenmesine ili\u015fkin \u00e7al\u0131\u015fmalar\u0131n\u0131 s\u00fcrd\u00fcr\u00fcyor. T\u00fcm destekleyici \u015firketler, Kurum&#8217;un klinik ara\u015ft\u0131rmalar i\u00e7in \u00f6ng\u00f6rd\u00fc\u011f\u00fc tedbirleri uygulamal\u0131, risk de\u011ferlendirmeleri yapmal\u0131 ve bunlar\u0131 s\u00fcre\u00e7lerine dahil etmelidir.<\/p>\n<p><strong>COVID-19\u2019un hukuki etkilerine y\u00f6nelik mevzuat b\u00fcltenlerimiz ve di\u011fer b\u00fcltenlerimize <\/strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=TVQybGEwY2U3ZW1YcHpsaVhrZDRrV1BqQkxZWnhFRFVudS90SWNxckVFdEh6OFJidlRIM0VtTG50WERQYk56RlF6VURJU2IyYVhPcEsrSjMxZDJMRDJEOTRNdmJhTjB4&amp;rh=ff005f7c7ba5a82a7dc6a1e0334c835c1fd096cc__;!!Hj9Y_P0nvg!Dzpb_4mWRwEjHepI_xdmBu3y8zSxDGGPpdMOro5dRynQFNAE-_MjCq1tlZbzXlng6DDYYw$\"><strong>Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131 Koronavir\u00fcs<\/strong><\/a><\/u><strong> Masas\u0131 adresinden ula\u015fabilirsiniz.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;Kurum&#8220;), 20 Nisan 2020 tarihinde yapt\u0131\u011f\u0131 duyuruda COVID-19 pandemisi nedeniyle klinik ara\u015ft\u0131rmalarda [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120,149],"tags":[92],"class_list":["post-16083","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","category-covid-19-tr","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Klinik Ara\u015ft\u0131rmalarda Uygulanacak COVID-19 Tedbirleri Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular Dok\u00fcman\u0131 Yay\u0131mland\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye 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