{"id":1831,"date":"2021-03-12T15:11:06","date_gmt":"2021-03-12T13:11:06","guid":{"rendered":"https:\/\/pdo.cumhuriyet.edu.tr\/?p=1831"},"modified":"2021-03-12T15:11:06","modified_gmt":"2021-03-12T13:11:06","slug":"tuseb-klinik-arastirma-projeleri-cagrisi","status":"publish","type":"post","link":"https:\/\/pdo.cumhuriyet.edu.tr\/?p=1831","title":{"rendered":"T\u00dcSEB – KL\u0130N\u0130K ARA\u015eTIRMA PROJELER\u0130 \u00c7A\u011eRISI"},"content":{"rendered":"
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\u00c7a\u011fr\u0131 Ba\u015flang\u0131\u00e7 Tarihi :<\/div>\n
10.02.2021<\/div>\n<\/div>\n
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\u00c7a\u011fr\u0131 Biti\u015f Tarihi :<\/div>\n
10.02.2022 23:59:00<\/div>\n<\/div>\n
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Bas\u0131l\u0131 Belge Son Teslim Tarihi :<\/div>\n
18.02.2022<\/div>\n<\/div>\n
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Genel A\u00e7\u0131klama :<\/div>\n
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KL\u0130N\u0130K ARA\u015eTIRMA PROJELER\u0130 \u00c7A\u011eRISI<\/strong><\/p>\n

\u00c7a\u011fr\u0131 Amac\u0131<\/strong><\/p>\n

Bu proje \u00e7a\u011fr\u0131s\u0131, \u00fclkemizin d\u0131\u015fa ba\u011f\u0131ml\u0131l\u0131\u011f\u0131n\u0131 azaltmak ve ekonomik avantaj sa\u011flamak \u00fczere gerekli klinik-d\u0131\u015f\u0131 ara\u015ft\u0131rma a\u015famalar\u0131 tamamlam\u0131\u015f; kimyasal, biyoteknolojik, biyomedikal ve biyobenzer \u00fcr\u00fcnlerin klinik \u00e7al\u0131\u015fmalar\u0131n\u0131n desteklenmesini hedeflemektedir. Ayr\u0131ca, yeni ila\u00e7 kombinasyonlar\u0131n\u0131 i\u00e7eren klinik ara\u015ft\u0131rmalar da \u00e7a\u011fr\u0131 kapsam\u0131nda desteklenebilecektir. \u00dclkemizde s\u0131n\u0131rl\u0131 say\u0131da yap\u0131lan ve genellikle yurtd\u0131\u015f\u0131na ba\u011f\u0131ml\u0131 olan bu ara\u015ft\u0131rmalar\u0131n \u00f6n\u00fcn\u00fc a\u00e7mak ve ara\u015ft\u0131rmac\u0131lar\u0131n te\u015fvik edilmesini sa\u011flamak ama\u00e7lanmaktad\u0131r.<\/p>\n

Bu \u00e7a\u011fr\u0131da \u00fclkemizde yeni ila\u00e7 geli\u015ftirilmesinin \u00f6n\u00fcn\u00fcn a\u00e7\u0131lmas\u0131 ve ila\u00e7 klinik \u00e7al\u0131\u015fmalar\u0131na ili\u015fkin tecr\u00fcbe, bilgi birikimi ve kalite k\u00fclt\u00fcr\u00fcn\u00fcn olu\u015fmas\u0131n\u0131n desteklenmesi hedeflenmektedir.<\/p>\n

\u00c7a\u011fr\u0131n\u0131n amac\u0131, ila\u00e7 geli\u015ftirilmesinde \u00f6nemli bir a\u015fama olan klinik ara\u015ft\u0131rmalara kaynak olu\u015fturmakt\u0131r. \u00c7a\u011fr\u0131 kapsam\u0131nda de\u011ferlendirmeye al\u0131nacak proje \u00f6nerilerinin katma de\u011ferinin y\u00fcksek olmas\u0131, bir hastal\u0131\u011f\u0131n tedavisine y\u00f6nelik, genel pop\u00fclasyona veya ki\u015fiye \u00f6zg\u00fc tedavi yakla\u015f\u0131mlar\u0131 i\u00e7ermesi ama\u00e7lanmaktad\u0131r.<\/p>\n

Bu \u00e7a\u011fr\u0131 program\u0131 ile gerekli klinik d\u0131\u015f\u0131 a\u015famalar\u0131 tamamlam\u0131\u015f, kimyasal, biyoteknolojik ve biyobenzer \u00fcr\u00fcnlere y\u00f6nelik klinik ara\u015ft\u0131rmalar\u0131n, yeni ila\u00e7 kombinasyonu ve yeni endikasyon \u00e7al\u0131\u015fmalar\u0131n\u0131n desteklenmesi hedeflenmektedir.<\/p>\n

T\u00fcrkiye\u2019de geli\u015ftirilmi\u015f ila\u00e7, a\u015f\u0131 veya t\u0131bbi cihaz adaylar\u0131n\u0131n \u00fcr\u00fcne d\u00f6n\u00fc\u015ft\u00fcr\u00fclmesi i\u00e7in T\u00dcSEB taraf\u0131ndan:<\/p>\n

1.\u00a0\u00a0\u00a0Ulusal d\u00fczeyde Faz I ile Faz II \u00e7al\u0131\u015fmalar\u0131 ger\u00e7ekle\u015ftirilecektir.<\/p>\n

2.\u00a0\u00a0\u00a0Uluslararas\u0131 d\u00fczeyde Faz III \u00e7al\u0131\u015fmas\u0131 desteklenecektir.<\/p>\n

T\u00fcrkiye\u2019de geli\u015ftirilmemi\u015f ila\u00e7, a\u015f\u0131 veya t\u0131bbi cihaz adaylar\u0131n\u0131n \u00fcr\u00fcne d\u00f6n\u00fc\u015ft\u00fcr\u00fclmesi i\u00e7in T\u00dcSEB taraf\u0131ndan:<\/p>\n

1.\u00a0\u00a0\u00a0Uluslararas\u0131 d\u00fczeyde ger\u00e7ekle\u015ftirilen Faz III \u00e7al\u0131\u015fmalar\u0131n\u0131n T\u00fcrkiye aya\u011f\u0131 desteklenecektir.<\/p>\n

\u00dcr\u00fcn\u00fcn T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu Mevzuatlar\u0131\u2019na uygun ve FDA\/USP\/EMA\/ICH\/ Avrupa Farmakopesi\u2019 nde yer alan \u00f6zellikleri sa\u011flayacak nitelikte olmas\u0131 hedeflenmektedir.<\/p>\n

\u00c7a\u011fr\u0131n\u0131n Kapsam\u0131<\/strong><\/p>\n

A\u015f\u0131lar, ila\u00e7lar ve t\u0131bbi cihazlar i\u00e7in, Ar-Ge a\u015famalar\u0131 sonucu ortaya \u00e7\u0131kan ve klinik d\u0131\u015f\u0131 a\u015famalarda kullan\u0131lm\u0131\u015f olan aday \u00fcr\u00fcnlerin;<\/p>\n

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  1. Klinik \u00e7al\u0131\u015fmalar i\u00e7in kullan\u0131lacak a\u015f\u0131 ve ila\u00e7 lotlar\u0131n\u0131n, t\u0131bbi cihazlarda prototiplerinin tercihen T\u00fcrkiye’de \u00fcretilmi\u015f olmas\u0131.<\/li>\n
  2. Ar-Ge a\u015famas\u0131n\u0131 tamamlam\u0131\u015f olmas\u0131. (THS 1-5D)<\/li>\n
  3. THS (Teknoloji Haz\u0131rl\u0131k Seviyesi) cetveline g\u00f6re 5D a\u015famas\u0131n\u0131 bitirmi\u015f olmas\u0131 (bkz.\u00a0THS Cetveli<\/a>)<\/li>\n
  4. GMP (\u0130yi \u0130malat Uygulamalar\u0131) \u015fartlar\u0131nda klinik ara\u015ft\u0131rmalara uygun lot \u00fcretiminin T\u00fcrkiye\u2019de yap\u0131lm\u0131\u015f olmas\u0131,<\/li>\n
  5. GLP (\u0130yi Laboratuvar Uygulamalar\u0131) \u015fartlar\u0131nda klinik d\u0131\u015f\u0131 ara\u015ft\u0131rmalar\u0131n yap\u0131lm\u0131\u015f olmas\u0131<\/li>\n
  6. Faz I klinik ara\u015ft\u0131rmalar i\u00e7in gerekli dok\u00fcmantasyon i\u015flemlerine haz\u0131r olmas\u0131<\/li>\n
  7. A\u015f\u0131 \u00e7al\u0131\u015fmalar\u0131na dair yap\u0131lacak klinik ara\u015ft\u0131rmalar i\u00e7in ilgili a\u015fa\u011f\u0131daki k\u0131lavuzun dikkate al\u0131narak ba\u015fvurunun yap\u0131lmas\u0131 gerekmektedir.\u00a0https:\/\/titck.gov.tr\/storage\/Archive\/2020\/announcement\/BeeriAlarnKlinikDDeerlendirilmesinelikinKlavuz_8b89348c-f0f0-45d4-b4d3-ab98b40fde0a.pdf<\/u><\/a><\/li>\n<\/ol>\n

    Bu \u00c7a\u011fr\u0131 Kapsam\u0131 D\u0131\u015f\u0131nda Tutulacak Konular \u015eunlard\u0131r:<\/strong><\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Yurt i\u00e7inde veya yurt d\u0131\u015f\u0131nda \u00fcretilmi\u015f ila\u00e7, a\u015f\u0131 ve t\u0131bbi cihazlara dair klinik d\u0131\u015f\u0131 (pre-klinik) ara\u015ft\u0131rmalar<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u0130la\u00e7 Yeniden Konumland\u0131rma ara\u015ft\u0131rmalar\u0131<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Epidemiyolojik kesitsel \u00e7al\u0131\u015fmalar<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Tarama \u00e7al\u0131\u015fmalar\u0131<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Geleneksel ve Tamamlay\u0131c\u0131 T\u0131p kategorisindeki \u00fcr\u00fcnlere y\u00f6nelik klinik ara\u015ft\u0131rmalar<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Bitkisel\/destekleyici tedavi \u00fcr\u00fcnlerine y\u00f6nelik klinik d\u0131\u015f\u0131 ve\/veya klinik ara\u015ft\u0131rmalar<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Kozmetikler ve veterinerlik uygulama alanlar\u0131 hedefli projeler.<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Teknoloji haz\u0131rl\u0131k seviyesi 5D ve alt\u0131nda olan temel Ar-Ge projeleri<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Biyomalzemeler<\/p>\n

    Ba\u015fvuru Yapabilecek Kurum\/Kurulu\u015f\/Ki\u015filer<\/strong><\/p>\n

    – Devlet ve vak\u0131f \u00fcniversiteleri<\/p>\n

    – Ara\u015ft\u0131rma enstit\u00fcleri<\/p>\n

    – Kamu ve \u00f6zel hastaneler<\/p>\n

    – Halk sa\u011fl\u0131\u011f\u0131yla ilgili birimler<\/p>\n

    – Sa\u011fl\u0131k alan\u0131nda faaliyet g\u00f6steren \u00f6zel kurulu\u015flar (ila\u00e7 end\u00fcstrisi, biyoteknoloji \u015firketleri, vb.) ve KOB\u0130\u2019ler<\/p>\n

    – Yurtd\u0131\u015f\u0131nda farkl\u0131 kurum ve kurulu\u015flarda \u00e7al\u0131\u015fan T.C. vatanda\u015f\u0131 ara\u015ft\u0131rmac\u0131lar.<\/p>\n

    – Teknokent ve kulu\u00e7ka merkezinde faaliyet g\u00f6steren firmalar.<\/p>\n

    Hedeflenen \u00c7\u0131kt\u0131:\u00a0<\/strong>Yerli imk\u00e2nlarla \u00fcretilmi\u015f a\u015f\u0131, ila\u00e7, t\u0131bbi cihaz ve sa\u011fl\u0131k teknolojilerine y\u00f6nelik \u00fcr\u00fcn odakl\u0131 klinik ara\u015ft\u0131rmalar.<\/p>\n

    Ba\u015fvuru Ekleri<\/strong><\/p>\n

    1.\u00a0\u00a0\u00a0\u00a0Klinik D\u0131\u015f\u0131 Ara\u015ft\u0131rma verilerine dair bulgular, Kalite dok\u00fcmanlar\u0131<\/strong>\u00a0(https:\/\/www.titck.gov.tr\/duyuru\/covid-19-asi-gelistirme-calismasi-yuruten-arastirma-gruplarinin-dikkatine-04092020215139<\/a>\u00a0)<\/p>\n

    2.\u00a0\u00a0\u00a0Klinik Ara\u015ft\u0131rma Verileri, raporlar\u0131 ve bulgular (Her bir faz\u0131n \u00f6ncesinde yap\u0131lan \u00e7al\u0131\u015fmalara dair)<\/strong><\/p>\n

    3.\u00a0\u00a0\u00a0\u00a0T\u0130TCK Kurum Onay\u0131 Belgesi veya ba\u015fvuru yap\u0131ld\u0131\u011f\u0131na dair belge<\/strong><\/p>\n

    4.\u00a0\u00a0\u00a0\u00a0Klinik ara\u015ft\u0131rma protokol\u00fc ve ekleri<\/strong>\u00a0(T\u00fcm ekler T\u0130TCK standart formuna g\u00f6re yap\u0131land\u0131r\u0131lacakt\u0131r)<\/p>\n

    5.\u00a0\u00a0\u00a0\u00a0Klinik ara\u015ft\u0131rma \u00fcr\u00fcn\u00fcne dair patent bilgisi, ba\u015fvurusu veya haz\u0131rl\u0131k a\u015famas\u0131ndaki evraklar\u0131 (mevcut ise)<\/strong><\/p>\n

    6.\u00a0\u00a0\u00a0\u00a0Yurt D\u0131\u015f\u0131 Ara\u015ft\u0131rmac\u0131 Bilgi Formu (Yurtd\u0131\u015f\u0131 ara\u015ft\u0131rmac\u0131 var ise)<\/p>\n

    7.\u00a0\u00a0\u00a0\u00a0T\u00fcrkiye\u2019de \u0130kamet Eden Yabanc\u0131 Uyruklulara PT\u0130 \u00d6denebilece\u011fine Dair Onay Belgesi (Gerekli ise)<\/p>\n

    8.\u00a0\u00a0\u00a0\u00a0T\u00dcSEB Ba\u015fkanl\u0131k Onay Yaz\u0131s\u0131 (\u0130\u015fbirli\u011fi ekibinde T\u00dcSEB Enstit\u00fclerinden y\u00fcr\u00fct\u00fcc\u00fc\/ara\u015ft\u0131rmac\u0131\/dan\u0131\u015fman bulunmas\u0131 halinde)<\/p>\n

    9.\u00a0\u00a0\u00a0\u00a0K\u00fc\u00e7\u00fck ve Orta B\u00fcy\u00fckl\u00fckte \u0130\u015fletme (KOB\u0130) olma \u015fartlar\u0131na ula\u015famam\u0131\u015f sermaye \u015firketleri ve KOB\u0130 niteli\u011findeki i\u015fletmelerin y\u00f6netici ve ortaklar\u0131n\u0131n ba\u015fvuru sahibi olmas\u0131 durumunda \u201cKOB\u0130 Beyannanmesi\u201d<\/p>\n

    10.\u00a0\u00a0\u00d6zel Kurulu\u015flardan Ek Olarak Talep Edilen Belgeler (Gerekli ise)<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Ticaret Sicil Gazetesi (\u015eirketin g\u00fcncel unvan ve adresinin yer ald\u0131\u011f\u0131 sayfa)<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Oda Sicil Kay\u0131t Sureti<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u0130mza Sirk\u00fcleri<\/p>\n

    \u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Yetki Belgesi (\u015eirketi temsile yetkili ki\u015finin belirtildi\u011fi ilgili Ticaret Sicil M\u00fcd\u00fcrl\u00fc\u011f\u00fc\u2019nden al\u0131nm\u0131\u015f belge)<\/p>\n

    11.\u00a0\u00a04691 Say\u0131l\u0131 Teknoloji Geli\u015ftirme B\u00f6lgeleri Kanunu Kapsam\u0131nda Faaliyet G\u00f6steren \u015eirketler B\u00fcnyesinde G\u00f6rev Yapan \u00dcniversite \u00d6\u011fretim Elemanlar\u0131 i\u00e7in Proje Ba\u015fvurusu \u0130zin Formu<\/p>\n

    12.\u00a0\u00a0Klinik Ara\u015ft\u0131rman\u0131n yap\u0131laca\u011f\u0131 merkezlerde kullan\u0131lacak cihaz listeleri<\/p>\n

    13.\u00a0\u00a0Referanslar\/Kaynaklar<\/strong><\/p>\n

    14.\u00a0\u00a0B\u00fct\u00e7e Formu<\/strong><\/p>\n

    15.\u00a0\u00a0Belirtmek \u0130stedi\u011finiz Di\u011fer Konular<\/p>\n

     <\/p>\n

    BA\u015eVURU DOK\u00dcMANLARI VE D\u0130KKAT ED\u0130LECEK HUSUSLAR<\/strong><\/p>\n

    Ba\u015fvurunun ge\u00e7erli say\u0131labilmesi i\u00e7in a\u015fa\u011f\u0131daki belgelerin imzal\u0131 olarak sunulmas\u0131 gerekmektedir.<\/p>\n