{"id":15005,"date":"2020-03-24T09:22:47","date_gmt":"2020-03-24T09:22:47","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=15005"},"modified":"2022-06-09T12:45:26","modified_gmt":"2022-06-09T12:45:26","slug":"klinik-arastirmalarda-uygulanacak-covid-19-tedbirleri","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2020\/03\/24\/klinik-arastirmalarda-uygulanacak-covid-19-tedbirleri\/","title":{"rendered":"Klinik Ara\u015ft\u0131rmalarda Uygulanacak COVID-19 Tedbirleri"},"content":{"rendered":"

Yeni Geli\u015fmeler<\/strong><\/p>\n

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum<\/strong>“), 20 Mart 2020 tarihinde yapt\u0131\u011f\u0131 duyuruda COVID-19 pandemisi nedeniyle klinik ara\u015ft\u0131rmalarda al\u0131nacak tedbirleri belirledi. Tedbirler, ara\u015ft\u0131rma merkezlerinin y\u00fck\u00fcn\u00fc azaltmay\u0131 ve g\u00f6n\u00fcll\u00fclerin g\u00fcvenli\u011fini sa\u011flamay\u0131 ama\u00e7l\u0131yor.<\/p>\n

Ne De\u011fi\u015fecek?<\/strong><\/p>\n

Kurum \u00f6ncelikli olarak destekleyicilerin devaml\u0131 olarak bir risk de\u011ferlendirmesi yapmas\u0131n\u0131, ara\u015ft\u0131rma organizasyonlar\u0131n\u0131 buna g\u00f6re koordine etmelerini ve g\u00fcncellemeleri gerekti\u011fini belirtti. Bu kapsamda ara\u015ft\u0131rmalar\u0131n niteli\u011fi g\u00f6z \u00f6n\u00fcnde bulundurularak gerekli hallerde ara\u015ft\u0131rman\u0131n ge\u00e7ici olarak durdurulmas\u0131 veya erken sonland\u0131r\u0131lmas\u0131n\u0131n ilk olarak de\u011ferlendirilmesi gerekiyor.<\/p>\n

G\u00f6n\u00fcll\u00fclerin g\u00fcvenli\u011fini etkileyebilecek yeni bir durumun ortaya \u00e7\u0131kmas\u0131 halinde, destekleyicilerin, sorumlu ara\u015ft\u0131rmac\u0131n\u0131n veya hekim ya da di\u015f hekimi olan ara\u015ft\u0131rmac\u0131lar\u0131n bu tehlikelere kar\u015f\u0131 g\u00f6n\u00fcll\u00fcleri koruyacak gerekli acil g\u00fcvenlik tedbirlerinin al\u0131nmas\u0131 gerekiyor. COVID-19 salg\u0131n\u0131na ili\u015fkin al\u0131nan g\u00fcvenlik \u00f6nlemleri, Etik Kuruldan onay ve Kurum’dan izin al\u0131nmadan uygulanabilecek.<\/p>\n

Klinik ara\u015ft\u0131rma s\u0131ras\u0131ndaki izleme faaliyetlerinde de\u011fi\u015fikli\u011fe gidilebilecek. Bu kapsamda merkez yerinde izleme faaliyetlerinin ertelenebilecek ve\/veya yeniden planlanabilecek. Kurum ayr\u0131ca, 6698 say\u0131l\u0131 Ki\u015fisel Verilerin Korunmas\u0131 Kanunu’na ve klinik ara\u015ft\u0131rmalarda gizlilik ilkelerine tabi olmak kayd\u0131yla, merkez yerinde izleme faaliyetlerinin ger\u00e7ekle\u015ftirilmesinin m\u00fcmk\u00fcn olmamas\u0131 halinde uzaktan izleme faaliyeti ger\u00e7ekle\u015ftirilebilece\u011fini belirtti.<\/p>\n

Ek olarak, g\u00fcmr\u00fck engelleri, karantina durumu gibi olas\u0131 senaryolar nedeni ile ara\u015ft\u0131rmada kullan\u0131lan \u00fcr\u00fcnlerin ara\u015ft\u0131rma merkezlerine yeterli say\u0131da sa\u011flanabilmesi i\u00e7in \u00fcr\u00fcn stoku normalden fazla tutulabilecek. Al\u0131nan tedbirler kapsam\u0131nda ara\u015ft\u0131rma merkezi ziyaretlerinden (g\u00f6n\u00fcll\u00fc vizitleri) m\u00fcmk\u00fcn olanlar\u0131n ertelenmesi, uygun durumlarda telefon viziti tercih edilmesi \u00f6ng\u00f6r\u00fcld\u00fc.<\/p>\n

Kurum, ara\u015ft\u0131rma toplant\u0131lar\u0131n\u0131n online olarak yap\u0131lmas\u0131na izin verilece\u011fini, y\u00fcz y\u00fcze yap\u0131lacak iyi klinik uygulamalar\u0131 ve klinik ara\u015ft\u0131rmalar hakk\u0131ndaki e\u011fitim veya toplant\u0131lara ise verilmeyece\u011fini belirtti.<\/p>\n

Kurum ayr\u0131ca, yap\u0131lacak klinik ara\u015ft\u0131rma ba\u015fvurular\u0131nda fiziksel evrak sunulmas\u0131na gerek duyulmayaca\u011f\u0131n\u0131 ve ba\u015fvurular\u0131n elektronik olarak yap\u0131laca\u011f\u0131n\u0131 ifade etti.<\/p>\n

Klinik ara\u015ft\u0131rmalarda al\u0131nacak tedbirlere ili\u015fkin Kurum duyurusuna buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Sonu\u00e7<\/strong><\/p>\n

Kurum, COVID-19 salg\u0131n\u0131n\u0131n \u00f6nlenmesine ili\u015fkin \u00e7al\u0131\u015fmalar\u0131n\u0131 s\u00fcrd\u00fcr\u00fcyor. T\u00fcm destekleyici \u015firketler, Kurum’un klinik ara\u015ft\u0131rmalar i\u00e7in \u00f6ng\u00f6rd\u00fc\u011f\u00fc tedbirleri uygulamal\u0131, risk de\u011ferlendirmeleri yapmal\u0131 ve Kurum’un bu konudaki a\u00e7\u0131klamalar\u0131n\u0131 takip etmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum“), 20 Mart 2020 tarihinde yapt\u0131\u011f\u0131 duyuruda COVID-19 pandemisi nedeniyle klinik ara\u015ft\u0131rmalarda […]<\/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-15005","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","category-covid-19-tr","tag-healthcare-tr"],"acf":[],"yoast_head":"\nKlinik Ara\u015ft\u0131rmalarda Uygulanacak COVID-19 Tedbirleri<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("Kurum"), 20 Mart 2020 tarihinde yapt\u0131\u011f\u0131 duyuruda COVID-19 pandemisi nedeniyle klinik ara\u015ft\u0131rmalarda\" \/>\n<meta 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