{"id":23657,"date":"2026-09-22T14:29:02","date_gmt":"2026-09-22T11:29:02","guid":{"rendered":"https:\/\/mirora.com\/?page_id=23657"},"modified":"2026-09-28T15:53:43","modified_gmt":"2026-09-28T12:53:43","slug":"klinik-arastirma-cevirisi","status":"publish","type":"page","link":"https:\/\/mirora.com\/tr\/klinik-arastirma-cevirisi\/","title":{"rendered":"Klinik Ara\u015ft\u0131rma \u00c7evirisi"},"content":{"rendered":"\t\t
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Medikal ve Ya\u015fam Bilimleri<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik Ara\u015ft\u0131rma \u00c7evirisi<\/span><\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma \u00e7evirisi, bir klinik \u00e7al\u0131\u015fman\u0131n y\u00fcr\u00fct\u00fclmesi i\u00e7in \u00fcretilen t\u00fcm belgeleri kapsar: \u00e7al\u0131\u015fman\u0131n nas\u0131l i\u015fleyece\u011fini tan\u0131mlayan protokolden, kat\u0131l\u0131mc\u0131lar\u0131n imzalad\u0131\u011f\u0131 onam formlar\u0131na ve sonu\u00e7lar\u0131 toplayan veri ara\u00e7lar\u0131na kadar. \u00c7ok uluslu bir \u00e7al\u0131\u015fma y\u00fczlerce belge \u00fcretebilir; bu alan\u0131 di\u011fer medikal \u00e7evirilerden ay\u0131ran \u015fey de tam olarak bu hacim ve \u00fczerindeki s\u0131k\u0131 d\u00fczenleyici g\u00f6zetimdir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tProjenizi G\u00f6r\u00fc\u015felim<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Klinik ara\u015ft\u0131rma deneyimimiz<\/div>\t\t\t\t<\/div>\n\t\t
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160+<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Son \u00fc\u00e7 y\u0131lda klinik \u00e7al\u0131\u015fma<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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30+ y\u0131l<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Medikal \u00e7eviri uzmanl\u0131\u011f\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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ISO 9001<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Belgeli kalite y\u00f6netim sistemi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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ISO 17100<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Uyumlu \u00e7eviri i\u015f ak\u0131\u015f\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Klinik Ara\u015ft\u0131rma Dok\u00fcmantasyonu<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130ki belge ak\u0131\u015f\u0131<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma belgeleri iki ayr\u0131 yoldan ilerler. Her yolun inceleyicisi, kalite \u00f6l\u00e7\u00fct\u00fc ve teslim bask\u0131s\u0131 farkl\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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01<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Hastaya Y\u00f6nelik Belgeler<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Hastaya y\u00f6nelik belgeleri etik kurullar ve kurumsal inceleme kurullar\u0131 (IRB) inceler. Bu metinlerde anla\u015f\u0131l\u0131rl\u0131k ve sadelik \u00f6n plandad\u0131r. Kat\u0131l\u0131mc\u0131n\u0131n \u00e7al\u0131\u015fmay\u0131, riskleri ve haklar\u0131n\u0131 anlayabilmesi i\u00e7in hedef kitlenin okuma d\u00fczeyine uygun bir dil gerekir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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02<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Sponsora Y\u00f6nelik Belgeler<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Sponsora y\u00f6nelik belgeleri ulusal d\u00fczenleyiciler inceler. Protokol, ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fc ve klinik \u00e7al\u0131\u015fma raporu gibi metinlerde bilimsel kesinlik, metodoloji dili ve terminolojik tutarl\u0131l\u0131k \u00f6n plandad\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Hastaya y\u00f6nelik metinde anla\u015f\u0131l\u0131rl\u0131k ve sadelik, sponsora y\u00f6nelik metinde bilimsel kesinlik \u00f6n plandad\u0131r. \u0130kisini ayn\u0131 kefeye koymak, birinde eksik, di\u011ferinde gereksiz \u00e7abaya yol a\u00e7ar.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Rakamlarla Deneyimimiz<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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160'tan fazla klinik \u00e7al\u0131\u015fma<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Otuz y\u0131l\u0131 a\u015fk\u0131n medikal uzmanl\u0131\u011f\u0131m\u0131zla, son \u00fc\u00e7 y\u0131lda 160’tan fazla klinik \u00e7al\u0131\u015fman\u0131n belgelerini eksiksiz ve titizlikle \u00e7evirdik.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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30+ y\u0131l<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Medikal uzmanl\u0131k<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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160+<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik \u00e7al\u0131\u015fma<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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ISO 9001<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kalite y\u00f6netimi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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ISO 17100<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Uyumlu i\u015f ak\u0131\u015f\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Klinik Ara\u015ft\u0131rma Belgeleri<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ba\u015fl\u0131ca belge t\u00fcrleri ve her birinin \u00f6zelli\u011fi<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma s\u00fcrecinde \u00e7evrilen belgeler ama\u00e7lar\u0131 ve okuyucular\u0131 bak\u0131m\u0131ndan birbirinden \u00e7ok farkl\u0131d\u0131r; her biri farkl\u0131 bir \u00fcslup ve do\u011frulama d\u00fczeyi ister.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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PROTOKOL \/ IB<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Protokol ve Ara\u015ft\u0131rmac\u0131 Bro\u015f\u00fcr\u00fc<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Protokol, \u00e7al\u0131\u015fman\u0131n bilimsel omurgas\u0131d\u0131r: ama\u00e7, tasar\u0131m, d\u00e2hil etme ve d\u0131\u015flama \u00f6l\u00e7\u00fctleri, dozaj ve g\u00fcvenlik izlemi burada tan\u0131mlan\u0131r. Ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fc ise \u00fcr\u00fcn\u00fcn klinik ve klinik d\u0131\u015f\u0131 verilerini ara\u015ft\u0131rmac\u0131ya \u00f6zetler. \u0130kisi de sponsora y\u00f6nelik, yo\u011fun bilimsel metinlerdir; \u00e7evirmenin t\u0131bbi terminolojinin yan\u0131 s\u0131ra istatistik ve metodoloji diline de h\u00e2kim olmas\u0131 gerekir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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ICF<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Bilgilendirilmi\u015f Onam Formu<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Onam formu, kat\u0131l\u0131mc\u0131n\u0131n \u00e7al\u0131\u015fmay\u0131, riskleri ve haklar\u0131n\u0131 anlayarak karar vermesini sa\u011flar. Bu y\u00fczden \u00f6l\u00e7\u00fct yaln\u0131zca do\u011fruluk de\u011fil, anla\u015f\u0131l\u0131rl\u0131kt\u0131r: hedef kitlenin okuma d\u00fczeyine uygun, sade bir dil beklenir. Onam formlar\u0131 etik kurul onay\u0131 gerektirir; talep h\u00e2linde back-translation ile anlam\u0131n korundu\u011fu ayr\u0131ca teyit edilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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CRF \/ eCRF<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Olgu Rapor Formu ve Hasta G\u00fcnl\u00fckleri<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Olgu rapor formu, her kat\u0131l\u0131mc\u0131dan toplanan verinin standart kayd\u0131d\u0131r ve g\u00fcn\u00fcm\u00fczde \u00e7o\u011funlukla elektronik (eCRF) olarak kullan\u0131l\u0131r. \u00c7evirisinin veri taban\u0131ndaki alan adlar\u0131yla birebir tutarl\u0131 olmas\u0131 gerekir; aksi h\u00e2lde veri giri\u015finde ve analizde kar\u0131\u015f\u0131kl\u0131k do\u011far. Hasta g\u00fcnl\u00fckleri ise hastan\u0131n kendi doldurdu\u011fu ara\u00e7lard\u0131r; anla\u015f\u0131l\u0131r olmal\u0131 ve dilsel do\u011frulamadan ge\u00e7melidir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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CSR<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik \u00c7al\u0131\u015fma Raporu<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u00c7al\u0131\u015fma tamamland\u0131\u011f\u0131nda sonu\u00e7lar klinik \u00e7al\u0131\u015fma raporunda toplan\u0131r ve ruhsat ba\u015fvurusunun bir par\u00e7as\u0131 olarak otoriteye sunulur. Rapor ICH E3 yap\u0131s\u0131na g\u00f6re d\u00fczenlenir; istatistik tablolar\u0131, g\u00fcvenlik verileri ve sonu\u00e7lar\u0131n yorumunu i\u00e7erir. \u00c7evirisinde tablo ve terminoloji tutarl\u0131l\u0131\u011f\u0131 belirleyicidir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Reg\u00fclasyon \u00c7er\u00e7eveleri<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma \u00e7evirisinde d\u00fczenleyici \u00e7er\u00e7eveler<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Bu alan birden fazla \u00e7er\u00e7eveye tabidir. Avrupa Birli\u011fi’nde Klinik Ara\u015ft\u0131rmalar T\u00fcz\u00fc\u011f\u00fc (EU CTR \u2014 (AB) 536\/2014) ba\u015fvuru ve belge gerekliliklerini belirler; k\u00fcresel \u00f6l\u00e7ekte \u0130yi Klinik Uygulamalar\u0131 standard\u0131 ICH E6(R3) ile klinik \u00e7al\u0131\u015fmalar\u0131n genel ilkelerini d\u00fczenleyen ICH E8(R1) ge\u00e7erlidir.<\/p>

T\u00fcrkiye’de klinik ara\u015ft\u0131rmalar T\u0130TCK’in g\u00f6zetiminde y\u00fcr\u00fct\u00fcl\u00fcr ve hastaya y\u00f6nelik belgeler etik kurul onay\u0131ndan ge\u00e7er. Kat\u0131l\u0131mc\u0131ya y\u00f6nelik belgelerde \u00e7o\u011fu zaman klinik uzman incelemesi, gerekti\u011finde de back-translation beklenir; \u00e7eviri s\u00fcr\u00fcmlerinin ve \u00e7evirmen niteliklerinin kayd\u0131 da tutulur.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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EU CTR<\/div>\t\t\t\t<\/div>\n\t\t
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(AB) 536\/2014<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Avrupa Birli\u011fi klinik ara\u015ft\u0131rmalar\u0131nda ba\u015fvuru ve belge gerekliliklerini belirleyen d\u00fczenleyici \u00e7er\u00e7eve.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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ICH<\/div>\t\t\t\t<\/div>\n\t\t
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ICH E6(R3)<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rmalarda \u0130yi Klinik Uygulamalar\u0131 standard\u0131.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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ICH<\/div>\t\t\t\t<\/div>\n\t\t
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ICH E8(R1)<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik \u00e7al\u0131\u015fmalar\u0131n genel ilkelerini d\u00fczenleyen \u00e7er\u00e7eve.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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ICH E3<\/div>\t\t\t\t<\/div>\n\t\t
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Klinik \u00c7al\u0131\u015fma Raporu<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik \u00e7al\u0131\u015fma raporlar\u0131n\u0131n yap\u0131s\u0131nda kullan\u0131lan temel ICH k\u0131lavuzu.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Kalite ve Dilsel Do\u011frulama<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Reg\u00fclasyona tabi belgelerde kontroll\u00fc kalite s\u00fcreci<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Reg\u00fclasyona tabi bir ortamda her belge, do\u011frulu\u011fu ve tutarl\u0131l\u0131\u011f\u0131 teyit eden bir do\u011frulama s\u00fcrecinden ge\u00e7er. Hastaya y\u00f6nelik ara\u00e7larda \u2014 onam formu, hasta g\u00fcnl\u00fc\u011f\u00fc, hastaya bildirilen sonu\u00e7 (PRO) anketleri \u2014 dilsel do\u011frulama, metnin hedef kitle taraf\u0131ndan do\u011fru anla\u015f\u0131lmas\u0131n\u0131 g\u00fcvence alt\u0131na al\u0131r; gerekti\u011finde bu s\u00fcrece hasta kat\u0131l\u0131m\u0131yla anla\u015f\u0131labilirlik testi de eklenir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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01 \/ ANAL\u0130Z<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Belge Analizi<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Belgenin t\u00fcr\u00fc, hedef kitlesi ve klinik \u00e7al\u0131\u015fma i\u00e7indeki kullan\u0131m amac\u0131 de\u011ferlendirilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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02 \/ TERM\u0130NOLOJ\u0130<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Terminoloji Y\u00f6netimi<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u00c7al\u0131\u015fma boyunca endikasyona \u00f6zg\u00fc terminoloji s\u00f6zl\u00fckleri kullan\u0131larak belgeler aras\u0131ndaki tutarl\u0131l\u0131k korunur.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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03 \/ \u00c7EV\u0130R\u0130<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Uzman \u00c7eviri<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130\u00e7erik, bilimsel do\u011fruluk ve hedef okuyucunun gereksinimleri dikkate al\u0131narak \u00e7evrilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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04 \/ REDAKS\u0130YON<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ba\u011f\u0131ms\u0131z Edit\u00f6r Kontrol\u00fc<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Her metin, \u00e7eviriyi yapan ki\u015fiden ba\u011f\u0131ms\u0131z bir uzman edit\u00f6r\u00fcn redaksiyonundan ge\u00e7er.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Protokol de\u011fi\u015fti\u011finde terminolojinin de g\u00fcncel tutulmas\u0131, s\u0131k atlanan ama kritik bir ayr\u0131nt\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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S\u0131k Yap\u0131lan Hatalar<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma \u00e7evirisinde hangi hatalar sorun yarat\u0131r?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma belgelerinde k\u00fc\u00e7\u00fck g\u00f6r\u00fcnen dilsel veya terminolojik farkl\u0131l\u0131klar \u00e7al\u0131\u015fma boyunca b\u00fcy\u00fcyebilir. Bunlar\u0131n her biri \u00e7al\u0131\u015fman\u0131n gecikmesine ya da belgenin geri d\u00f6nmesine yol a\u00e7abilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tHastaya y\u00f6nelik metni bilimsel \u00fcslupla \u00e7evirmek ve anla\u015f\u0131l\u0131rl\u0131\u011f\u0131 kaybetmek.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tProtokol de\u011fi\u015fikliklerinden sonra terminolojiyi g\u00fcncellememek ve belgeler aras\u0131nda tutars\u0131zl\u0131k yaratmak.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tCRF alan adlar\u0131n\u0131 veri taban\u0131yla e\u015fle\u015ftirmeden \u00e7evirmek.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tTarih, birim ve ondal\u0131k ay\u0131r\u0131c\u0131 gibi bi\u00e7imleri hedef \u00fclkeye uyarlamamak.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\tEtik kurulun bekledi\u011fi bi\u00e7im ve ba\u015fl\u0131k yap\u0131s\u0131n\u0131 g\u00f6zetmemek.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Deneyim ve S\u00fcre\u00e7<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Medikal \u00e7eviride 30 y\u0131l\u0131 a\u015fk\u0131n uzmanl\u0131k<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Otuz y\u0131l\u0131 a\u015fk\u0131n s\u00fcredir medikal \u00e7eviride uzmanla\u015fan Mirora, ISO 9001 belgeli ve ISO 17100 ile uyumlu i\u015f ak\u0131\u015f\u0131yla \u00f6nde gelen ila\u00e7 \u015firketleri ve klinik ara\u015ft\u0131rma kurulu\u015flar\u0131n\u0131n tercih etti\u011fi \u00e7eviri orta\u011f\u0131d\u0131r.<\/p>

\u00c7al\u0131\u015fma boyunca endikasyona \u00f6zg\u00fc terminoloji s\u00f6zl\u00fckleri tutarl\u0131l\u0131\u011f\u0131 korur ve her metin ba\u011f\u0131ms\u0131z bir edit\u00f6r\u00fcn redaksiyonundan ge\u00e7er.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Vaka \u00c7al\u0131\u015fmas\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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On y\u0131l\u0131 a\u015fk\u0131n bir i\u015f birli\u011finin son \u00fc\u00e7 y\u0131l\u0131<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Uluslararas\u0131 bir ila\u00e7 kurulu\u015fuyla on y\u0131l\u0131 a\u015fk\u0131n s\u00fcredir birlikte \u00e7al\u0131\u015f\u0131yoruz. Yaln\u0131zca son \u00fc\u00e7 y\u0131lda, yaln\u0131zca bu kurum i\u00e7in 1.385 proje tamamlad\u0131k ve 3,9 milyon s\u00f6zc\u00fc\u011f\u00fcn \u00fczerinde \u00e7eviri ger\u00e7ekle\u015ftirdik; her y\u0131l 76 ila 81 klinik \u00e7al\u0131\u015fman\u0131n belgelerini i\u015fledik.<\/p>

Bu s\u00fcre boyunca t\u00fcm projelerde tek bir terminoloji s\u00f6zl\u00fc\u011f\u00fc kulland\u0131k ve her belgeyi, \u00e7eviriyi yapan ki\u015fiden ba\u011f\u0131ms\u0131z bir uzman edit\u00f6r\u00fcn redaksiyonundan ge\u00e7irdik.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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10+ y\u0131l<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Devam eden i\u015f birli\u011fi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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1.385<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Son \u00fc\u00e7 y\u0131ldaki proje<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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3,9M+<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u00c7evrilen s\u00f6zc\u00fck<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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76\u201381<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Y\u0131ll\u0131k klinik \u00e7al\u0131\u015fma<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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K\u0131sa Terim S\u00f6zl\u00fc\u011f\u00fc<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma \u00e7evirisinde kullan\u0131lan temel terimler<\/h2>\t\t\t\t<\/div>\n\t\t
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ICF<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Bilgilendirilmi\u015f onam formu.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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CRF \/ eCRF<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Olgu rapor formu ve elektronik s\u00fcr\u00fcm\u00fc.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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CSR<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik \u00e7al\u0131\u015fma raporu.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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IB<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fc.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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IRB \/ Etik Kurul<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Hastaya y\u00f6nelik belgeleri onaylayan kurul.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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GCP<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130yi Klinik Uygulamalar\u0131.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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PRO<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Hastaya bildirilen sonu\u00e7 \u00f6l\u00e7\u00fcm\u00fc.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Sponsor<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u00c7al\u0131\u015fmay\u0131 ba\u015flatan ve finanse eden kurulu\u015f.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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CRO<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Sponsor ad\u0131na \u00e7al\u0131\u015fmay\u0131 y\u00fcr\u00fcten s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015fu.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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S\u0131k Sorulan Sorular<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma \u00e7evirisi hakk\u0131nda s\u0131k sorulan sorular<\/h2>\t\t\t\t<\/div>\n\t\t
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Klinik ara\u015ft\u0131rma \u00e7evirisi neden ayr\u0131 bir uzmanl\u0131k alan\u0131? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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S\u0131k\u0131 d\u00fczenleyici g\u00f6zetim, \u00e7ok say\u0131da belge t\u00fcr\u00fc ve hastaya y\u00f6nelik materyallerde beklenen ek do\u011frulama ad\u0131mlar\u0131, onu genel medikal \u00e7eviriden ay\u0131r\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Hangi belgeler \u00e7evrilir? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Ba\u015fl\u0131calar\u0131 protokol, ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fc, onam formu (ICF), olgu rapor formu (CRF), hasta g\u00fcnl\u00fckleri ve klinik \u00e7al\u0131\u015fma raporudur (CSR).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Onam formu \u00e7evirisinde back-translation neden istenir? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Onam formu do\u011frudan hastaya y\u00f6nelik oldu\u011fu i\u00e7in anlam\u0131n do\u011fru aktar\u0131ld\u0131\u011f\u0131ndan emin olmak gerekir; bu nedenle talep \u00fczerine ba\u011f\u0131ms\u0131z bir geri \u00e7eviri yap\u0131l\u0131r ve \u00e7o\u011fu zaman etik kurul onay\u0131 al\u0131n\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Protokol de\u011fi\u015fiklikleri terminolojiyi nas\u0131l etkiler? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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\u00c7al\u0131\u015fma sabit kalmaz; her de\u011fi\u015fiklikte terminoloji de g\u00fcncellenmelidir, aksi h\u00e2lde belgeler aras\u0131nda tutars\u0131zl\u0131k do\u011far.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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CRF \u00e7evirisinde en kritik nokta nedir? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Alan adlar\u0131n\u0131n veri taban\u0131yla birebir tutarl\u0131 olmas\u0131; tek bir farkl\u0131 ifade, veri giri\u015finde ve analizde kar\u0131\u015f\u0131kl\u0131\u011fa yol a\u00e7ar.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Hangi standartlar \u00f6ne \u00e7\u0131kar? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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ICH \u0130yi Klinik Uygulamalar\u0131, EU CTR, ICH E3 (rapor yap\u0131s\u0131) ve ISO 9001\/17100; al\u0131c\u0131lar bu \u00e7er\u00e7evelerle uyumlu sa\u011flay\u0131c\u0131lar\u0131 tercih eder.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Klinik ara\u015ft\u0131rma \u00e7eviri projenizi Mirora ile g\u00f6r\u00fc\u015f\u00fcn<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik ara\u015ft\u0131rma belgelerinizin kapsam\u0131n\u0131, dil \u00e7iftlerini ve proje gereksinimlerini bizimle payla\u015f\u0131n. Protokolden ICF ve CRF’lere, hasta g\u00fcnl\u00fcklar\u0131ndan klinik \u00e7al\u0131\u015fma raporlar\u0131na kadar ihtiya\u00e7lar\u0131n\u0131za uygun \u00e7eviri s\u00fcrecini birlikte planlayal\u0131m.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tProjeniz \u0130\u00e7in \u0130leti\u015fime Ge\u00e7in \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Medikal ve Ya\u015fam Bilimleri Klinik Ara\u015ft\u0131rma \u00c7evirisi Klinik ara\u015ft\u0131rma \u00e7evirisi, bir klinik \u00e7al\u0131\u015fman\u0131n y\u00fcr\u00fct\u00fclmesi i\u00e7in \u00fcretilen t\u00fcm belgeleri kapsar: \u00e7al\u0131\u015fman\u0131n…<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-23657","page","type-page","status-publish","hentry"],"yoast_head":"\nKlinik Ara\u015ft\u0131rma \u00c7evirisi Nedir? | Mirora<\/title>\n<meta name=\"description\" content=\"Klinik ara\u015ft\u0131rma \u00e7evirisi: belge t\u00fcrleri (protokol, ICF, CRF, CSR), reg\u00fclasyon \u00e7er\u00e7eveleri (EU CTR, ICH-GCP), dilsel do\u011frulama ve s\u0131k yap\u0131lan hatalar.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mirora.com\/tr\/klinik-arastirma-cevirisi\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Klinik Ara\u015ft\u0131rma \u00c7evirisi Nedir? 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