{"id":735,"date":"2020-10-25T21:57:40","date_gmt":"2020-10-25T21:57:40","guid":{"rendered":"https:\/\/bloggcp.pl\/?page_id=735"},"modified":"2021-04-23T18:03:16","modified_gmt":"2021-04-23T18:03:16","slug":"pytania-do-audytora","status":"publish","type":"page","link":"https:\/\/bloggcp.pl\/index.php\/pytania-do-audytora\/","title":{"rendered":"Dodane w Sieci"},"content":{"rendered":"\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p>Tutaj, znajdziecie Pa\u0144stwo efekty dzia\u0142ania autora w sieci, czyli wpisy na FB i LinkedIn. <\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"801\" src=\"https:\/\/bloggcp.pl\/wp-content\/uploads\/2021\/04\/2021-02-FDA-falszerstwo-pic-01.jpg\" alt=\"\" class=\"wp-image-785\" srcset=\"https:\/\/bloggcp.pl\/wp-content\/uploads\/2021\/04\/2021-02-FDA-falszerstwo-pic-01.jpg 800w, https:\/\/bloggcp.pl\/wp-content\/uploads\/2021\/04\/2021-02-FDA-falszerstwo-pic-01-300x300.jpg 300w, https:\/\/bloggcp.pl\/wp-content\/uploads\/2021\/04\/2021-02-FDA-falszerstwo-pic-01-150x150.jpg 150w, https:\/\/bloggcp.pl\/wp-content\/uploads\/2021\/04\/2021-02-FDA-falszerstwo-pic-01-768x769.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><figcaption><a href=\"https:\/\/www.facebook.com\/bloggcppl\/posts\/237587758142722\">https:\/\/www.facebook.com\/bloggcppl\/posts\/237587758142722<\/a><\/figcaption><\/figure>\n\n\n\n<p><br><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Post FB 2021-04-23 O\u015brodek Fa\u0142szowania Bada\u0144 klinicznych!!<\/h2>\n\n\n\n<p><br>28 lat w wi\u0119zieniu, wyp\u0142ata ponad 1.8 mln USD i przepadek ponad 5.5 mln USD to zas\u0105dzona kara dla organizatora o\u015brodka fa\u0142szowania bada\u0144 klinicznych. W Richland, Washington w USA, pan Sami Anawar dopu\u015bci\u0142 si\u0119, w latach 2013-2018, czyli nie tak niedawno, systemowego fa\u0142szowania bada\u0144 klinicznych produkt\u00f3w leczniczych. Prowadz\u0105c plac\u00f3wk\u0119 medyczn\u0105, sam bra\u0142 czynny udzia\u0142 i zmusza\u0142, szanta\u017cem i gro\u017abami swoich wsp\u00f3\u0142pracownik\u00f3w do fa\u0142szowania danych w badaniach robionych dla wielu firm farmaceutycznych. Do standardowych praktyk nale\u017ca\u0142o fa\u0142szowanie EKG, podawanie nieprawdziwych parametr\u00f3w \u017cyciowych. Te fa\u0142szywe dane, &#8222;u\u0142atwia\u0142y&#8221; w\u0142\u0105czenie do badania uczestnik\u00f3w niespe\u0142niaj\u0105cych kryteri\u00f3w protoko\u0142u. Fa\u0142szowano te\u017c przebieg badania i zapisy w dzienniczkach uczestnik\u00f3w. Udowodniono panu Anawarowi, r\u00f3wnie\u017c pobieranie krwi od personelu o\u015brodka, kt\u00f3re to pr\u00f3bki podstawia\u0142 jako pr\u00f3bki uczestnik\u00f3w. R\u00f3wnie\u017c mia\u0142y miejsce nieprawid\u0142owo\u015bci w stosowaniu produkt\u00f3w leczniczych, w tym ich niepodawanie. Oczywi\u015bcie nie robi\u0142 tego, sam opr\u00f3cz tych wsp\u00f3\u0142pracownik\u00f3w, kt\u00f3rzy mu dobrowolnie pomagali, a z kt\u00f3rych dwie osoby zosta\u0142y r\u00f3wnie\u017c skazane, w proceder pod przymusem, przy u\u017cyciu mobbingu, zastraszania by\u0142o zaanga\u017cowane kilkoro pracownik\u00f3w. Wyrok zosta\u0142 wydany w pa\u017adzierniku 2020. Nie uda\u0142o mi si\u0119 znale\u017a\u0107 informacji, czy kto\u015b sprawdza, na ile te fa\u0142szywe badania wp\u0142yn\u0119\u0142y na skuteczne zarejestrowanie lek\u00f3w. Wydaje si\u0119, na podstawie dost\u0119pnych artyku\u0142\u00f3w, \u017ce ca\u0142a sprawa wyp\u0142yn\u0119\u0142a jako pochodna \u015bledztwa federalnej agencji DEA w sprawie nielegalnego obrotu opioidami, kt\u00f3re maj\u0105 w ostatnich latach fataln\u0105 &#8222;pras\u0119&#8221; w USA.<br>Oczywi\u015bcie, nieuzasadnione jest wyci\u0105ganie wniosk\u00f3w co do skali zjawiska, chocia\u017c nasuwa si\u0119 pytanie, czy nasze standardowe metody oceny, badania jako\u015bci i nadzoru nad badaniami s\u0105 w stanie w skuteczny, a nie przypadkowy spos\u00f3b, doprowadzi\u0107 do wykrycia takich przypadk\u00f3w?<br>2021-04-23<\/p>\n<\/div><\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tutaj, znajdziecie Pa\u0144stwo efekty dzia\u0142ania autora w sieci, czyli wpisy na FB i LinkedIn. Post FB 2021-04-23 O\u015brodek Fa\u0142szowania Bada\u0144 klinicznych!! 28 lat w wi\u0119zieniu, wyp\u0142ata ponad 1.8 mln USD i przepadek ponad 5.5 mln USD to zas\u0105dzona kara dla organizatora o\u015brodka fa\u0142szowania bada\u0144 klinicznych. W Richland, Washington w USA, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Dodane w Sieci - KOSIERADZKI.com<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bloggcp.pl\/index.php\/pytania-do-audytora\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dodane w Sieci - KOSIERADZKI.com\" \/>\n<meta property=\"og:description\" content=\"Tutaj, znajdziecie Pa\u0144stwo efekty dzia\u0142ania autora w sieci, czyli wpisy na FB i LinkedIn. 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