{"id":3730,"date":"2024-06-05T10:44:19","date_gmt":"2024-06-05T01:44:19","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&#038;p=3730"},"modified":"2024-06-13T13:19:46","modified_gmt":"2024-06-13T04:19:46","slug":"%ec%9d%98%eb%a3%8c-%eb%b0%8f-%ec%9e%84%ec%83%81-%ec%97%b0%ea%b5%ac%ec%97%90%ec%84%9c-%ed%95%84%ec%88%98%ec%a0%81%ec%9d%b8-ecoa%ec%99%80-linguistic-validation","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/%ec%9d%98%eb%a3%8c-%eb%b0%8f-%ec%9e%84%ec%83%81-%ec%97%b0%ea%b5%ac%ec%97%90%ec%84%9c-%ed%95%84%ec%88%98%ec%a0%81%ec%9d%b8-ecoa%ec%99%80-linguistic-validation\/","title":{"rendered":"\uc758\ub8cc \ubc0f \uc784\uc0c1 \uc5f0\uad6c\uc5d0\uc11c \ud544\uc218\uc801\uc778 eCOA\uc640 Linguistic Validation"},"content":{"rendered":"\n<p>\uc758\ub8cc \ubc0f \uc784\uc0c1 \uc5f0\uad6c\uc5d0\uc11c eCOA\uc640 Linguistic Validation (\uc5b8\uc5b4 \uac80\uc99d)\uc774 \uc65c \uc911\uc694\ud55c\uc9c0 \uc54c\uc544\ubcf4\uc138\uc694. \ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \uc0dd\uba85\uacfc\ud559 \ubc88\uc5ed\uc758 \uc804\ubb38\uac00\ub85c, \uc5b8\uc5b4 \uac80\uc99d\uacfc eCOA \uad00\ub9ac\uc5d0 \ud0c1\uc6d4\ud55c \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-ecoa\ub780-\ubb34\uc5c7\uc77c\uae4c\uc694\">eCOA\ub780 \ubb34\uc5c7\uc77c\uae4c\uc694?<\/h3>\n\n\n\n<p>eCOA (electronic Clinical Outcome Assessment)\ub294 \uc804\uc790 \uc784\uc0c1 \uacb0\uacfc \ud3c9\uac00\ub97c \uc758\ubbf8\ud558\uba70, \uc804\uc790 \uc7a5\uce58, \uc989, \uc2a4\ub9c8\ud2b8\ud3f0, \ud0dc\ube14\ub9bf, \ucef4\ud4e8\ud130 \ub4f1\uc744 \uc0ac\uc6a9\ud558\uc5ec \ud658\uc790 \ubcf4\uace0 \uacb0\uacfc(PRO), \uc784\uc0c1\uc758 \ud3c9\uac00, \ub610\ub294 \uad00\ucc30\uc790 \ubcf4\uace0 \uacb0\uacfc\ub97c \uc218\uc9d1\ud558\ub294 \uc2dc\uc2a4\ud15c\uc744 \ub9d0\ud569\ub2c8\ub2e4. \uc2a4\ub9c8\ud2b8\uae30\uae30\ub97c \ud65c\uc6a9\ud558\uc5ec \ud658\uc790\uac00 \uc9c1\uc811 \uc790\uc2e0\uc758 \uc99d\uc0c1\uacfc \uacbd\ud5d8\uc744 \uae30\ub85d\ud558\uace0 \uc784\uc0c1\uc758\ub098 \uad00\ucc30\uc790\ub3c4 \uc2a4\ub9c8\ud2b8\ud3f0, \ud0dc\ube14\ub9bf, \ucef4\ud4e8\ud130 \ub4f1\uc744 \uc0ac\uc6a9\ud558\uc5ec \ub370\uc774\ud130\ub97c \uc785\ub825\ud558\uace0 \uad00\ub9ac\ud569\ub2c8\ub2e4. \uc774\ub294 \uae30\uc874\uc758 \uc885\uc774 \ubb38\uc9c4\ud45c\ub97c \ub300\uccb4\ud558\uc5ec \ub370\uc774\ud130 \uc218\uc9d1\uc758 \uc815\ud655\uc131\uacfc \ud6a8\uc728\uc131\uc744 \ub192\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"840\" height=\"268\" src=\"http:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-43.png\" alt=\"\" class=\"wp-image-3780\" srcset=\"https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-43.png 840w, https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-43-300x96.png 300w, https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/01-image1026_240508-43-768x245.png 768w\" sizes=\"auto, (max-width: 840px) 100vw, 840px\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-linguistic-validation-\uc5b8\uc5b4\uac80\uc99d-\uc740-\ubb34\uc5c7\uc778\uac00\uc694\">Linguistic Validation (\uc5b8\uc5b4\uac80\uc99d)\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/h3>\n\n\n\n<p>eCOA \uc2dc\uc2a4\ud15c\uc740 \ub2e4\uc591\ud55c \uc5b8\uc5b4\ub85c \uc81c\uacf5\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub54c \ud544\uc694\ud55c \uac83\uc774 Linguistic Validation (\uc5b8\uc5b4 \uac80\uc99d) \uc785\ub2c8\ub2e4. \uccb4\uacc4\uc801\uc778 \uc5b8\uc5b4 \uac80\uc99d\uc744 \ud1b5\ud574 eCOA \uc2dc\uc2a4\ud15c\uc5d0\uc11c \uc0ac\uc6a9\ub418\ub294 \uc9c8\ubb38\uc9c0\ub098 \ud3c9\uac00 \ub3c4\uad6c\uc5d0 \ub300\ud55c \uac01 \uc5b8\uc5b4 \ubc84\uc804\uc758 \uc77c\uad00\uc131\uacfc \uc815\ud655\uc131\uc744 \ud655\ubcf4\ud560 \uc218 \uc788\uae30 \ub54c\ubb38\uc5d0 \ubaa8\ub4e0 \ucc38\uc5ec\uc790\ub4e4\ub85c\ubd80\ud130 \uc815\ud655\ud55c \ub370\uc774\ud130\ub97c \uc218\uc9d1\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc5b8\uc5b4 \uac80\uc99d\uc740 \uc784\uc0c1\uc2dc\ud5d8\uc9c0\uc758 \ubb38\uc7a5\uacfc \uc6a9\uc5b4\ub4e4\uc774 \ud0c0\uac9f \uc5b8\uc5b4\uc640 \ubb38\ud654\uc5d0 \ub9de\uac8c \uc815\ud655\ud558\uac8c \ubc88\uc5ed\ub418\uc5c8\ub294\uc9c0 \ud655\uc778\ud558\ub294 \uc808\ucc28\uc785\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uac01 \uad6d\uac00\uc758 \ud658\uc790\ub098 \uc784\uc0c1\uc2dc\ud5d8 \ucc38\uac00\uc790\ub4e4\uc774 \uc815\ud655\ud558\uac8c eCOA \uc2dc\uc2a4\ud15c\uc744 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc5b8\uc5b4 \uac80\uc99d\uc740 \uac00\uc7a5 \ubcf5\uc7a1\ud55c \ubc88\uc5ed \ubc29\ubc95 \uc911 \ud558\ub098\ub85c \uc758\ub8cc, \uc81c\uc57d, \uc0dd\uba85 \uacfc\ud559 \ubc88\uc5ed\uc5d0\ub9cc \uc801\uc6a9\ub418\ub294 \ubc29\ubc95\ub860\uc785\ub2c8\ub2e4. \ubc88\uc5ed \uae30\uc220\uc740 \ubb3c\ub860, \ud658\uc790 \ub300\uba74 \uc790\ub8cc\uac00 \ud2b9\uc815 \ud658\uc790 \uc0c1\ud0dc\uc5d0\uc11c \uc5b4\ub5bb\uac8c \uc0ac\uc6a9\ub418\ub294\uc9c0 \uae4a\uc740 \uc774\ud574\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-linguistic-validation-\uc5b8\uc5b4-\uac80\uc99d-\uc774-\ud544\uc694\ud55c-\uc601\uc5ed\uc740-\uc5b4\ub514\uc778\uac00\uc694\">Linguistic Validation (\uc5b8\uc5b4 \uac80\uc99d)\uc774 \ud544\uc694\ud55c \uc601\uc5ed\uc740 \uc5b4\ub514\uc778\uac00\uc694?<\/h3>\n\n\n\n<p>\uc5b8\uc5b4 \uac80\uc99d\uc774 \ud544\uc694\ud55c \uc8fc\uc694 \uc601\uc5ed\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uccab\uc9f8, \uc784\uc0c1\uc2dc\ud5d8\uc5d0\uc11c \uc0ac\uc6a9\ud558\ub294 \ubb38\uc9c4\ud45c\uc640 \uc124\ubb38\uc9c0\uc785\ub2c8\ub2e4. \uc774\ub294 \ud658\uc790\uc758 \uc758\uacac\uacfc \uacbd\ud5d8\uc744 \uc815\ud655\ud558\uac8c \ubc18\uc601\ud574\uc57c \ud558\ubbc0\ub85c \uc5b8\uc5b4\uc640 \ubb38\ud654\uc801 \uc801\ud569\uc131\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub458\uc9f8, \uc758\ub8cc\uae30\uae30 \uc0ac\uc6a9\uc124\uba85\uc11c, \uc81c\ud488\ub77c\ubca8, \uc548\ub0b4\ubb38 \ub4f1 \uc81c\ud488 \ubb38\uc11c\ub4e4\uc785\ub2c8\ub2e4. \ud658\uc790\uc640 \uc758\ub8cc\uc9c4\uc774 \uc62c\ubc14\ub974\uac8c \uc774\ud574\ud558\uace0 \uc0ac\uc6a9\ud560 \uc218 \uc788\ub3c4\ub85d \ubb38\ud654\uc801\uc73c\ub85c \uc801\ud569\ud55c \ubc88\uc5ed\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc14b\uc9f8, \uc5f0\uad6c\uacb0\uacfc\ubcf4\uace0\uc11c, \ub17c\ubb38 \ub4f1 \ud559\uc220 \ubb38\uc11c\ub4e4\uc785\ub2c8\ub2e4. \uc774\ub4e4\uc740 \uc815\ud655\ud558\uace0 \ubb38\ud654\uc801\uc73c\ub85c \uc801\uc808\ud55c \ubc88\uc5ed\uc744 \ud1b5\ud574 \ub2e4\uc591\ud55c \uc5b8\uc5b4\ub85c \uc804\ud30c\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub137\uc9f8, \uc81c\uc57d\ud68c\uc0ac\ub4e4\uc774 \uaddc\uc81c\uae30\uad00\uc5d0 \uc81c\ucd9c\ud558\ub294 \uc784\uc0c1\uc2e0\uccad\uc11c\uc785\ub2c8\ub2e4. \uc774 \ub610\ud55c \uc5ec\ub7ec \uc5b8\uc5b4\ub85c \ubc88\uc5ed\ub418\uc5b4\uc57c \ud558\uba70 \uc5b8\uc5b4\uac80\uc99d\uc774 \uc218\ubc18\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774\uc678\uc5d0\ub3c4 \uc758\ub8cc \ubc0f \ubc14\uc774\uc624 \ubd84\uc57c\uc5d0\uc11c \uc0ac\uc6a9\ub418\ub294 \ub300\ubd80\ubd84\uc758 \ubb38\uc11c\uc640 \ub3c4\uad6c\uc5d0\uc11c \uc5b8\uc5b4 \uac80\uc99d\uc774 \uc911\uc694\ud55c \uc5ed\ud560\uc744 \uc218\ud589\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uc5b8\uc5b4-\uac80\uc99d-\ud504\ub85c\uc138\uc2a4-\uc54c\uc544\ubcf4\uae30\">\uc5b8\uc5b4 \uac80\uc99d \ud504\ub85c\uc138\uc2a4 \uc54c\uc544\ubcf4\uae30<\/h3>\n\n\n\n<p>\ud658\uc790 \ubcf4\uace0 \uacb0\uacfc (PRO)\uc758 \ubc88\uc5ed \ud604\uc9c0\ud654\uc5d0 \uc801\uc6a9\ud560 \uc9c0\uce68\uc744 \ub2f4\uace0 \uc788\ub294 <a href=\"https:\/\/www.ispor.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISPOR<\/a> (International Society for Pharmacoeconomics and Outcomes Research) <a href=\"https:\/\/www.ispor.org\/heor-resources\/good-practices\/article\/principles-of-good-practice-for-the-translation-and-cultural-adaptation-process-for-patient-reported-outcomes-(pro)-measures\" target=\"_blank\" rel=\"noreferrer noopener\">\uac00\uc774\ub4dc\ub77c\uc778<\/a>\uc740 \uc5b8\uc5b4 \uac80\uc99d \ud504\ub85c\uc138\uc2a4\ub97c \uc544\ub798\uc640 \uac19\uc774 \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"490\" height=\"164\" src=\"http:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/02-image1026_240508-24.png\" alt=\"\" class=\"wp-image-3782\" srcset=\"https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/02-image1026_240508-24.png 490w, https:\/\/hansem.com\/wp-content\/uploads\/2024\/06\/02-image1026_240508-24-300x100.png 300w\" sizes=\"auto, (max-width: 490px) 100vw, 490px\" \/><\/figure>\n\n\n\n<p>\uccab\uc9f8, 2\uba85\uc758 \uc804\ubb38 \ubc88\uc5ed\uac00\uac00 \uc6d0\ubb38\uc744 \ud0c0\uae43 \uc5b8\uc5b4\ub85c \ubc88\uc5ed\ud569\ub2c8\ub2e4. Dual <strong>Forward Translation<\/strong><\/p>\n\n\n\n<p>\ub458\uc9f8, \ubc88\uc5ed\ubb38\uc774 \uc6d0\ubb38\uc758 \uc758\ubbf8\ub97c \uc815\ud655\ud788 \uc804\ub2ec\ud558\uace0 \uc788\ub294\uc9c0 \ud655\uc778\ud558\uae30 \uc704\ud574 \uc804\ubb38\uac00\uc758 \ub9ac\ubdf0 \uacfc\uc815\uc744 \uac70\uce69\ub2c8\ub2e4. \uc774 \ub54c \ub9ac\ubdf0\uc5b4\ub294 \ub450 \uac00\uc9c0 \ubc88\uc5ed\uc744 \ube44\uad50\ud558\uc5ec \ucd5c\uc0c1\uc758 \ubc88\uc5ed\uc744 \uc774\ub04c\uc5b4 \ub0c5\ub2c8\ub2e4. \u00a0<strong>Reconciliation<\/strong><\/p>\n\n\n\n<p>\uc14b\uc9f8, \ub2e4\ub978 \ubc88\uc5ed\uac00\uac00 \ubc88\uc5ed\ubb38\uc744 \uc6d0\ubb38\uc758 \uc5b8\uc5b4\ub85c \uc5ed\ubc88\uc5ed\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \ubc88\uc5ed \uc815\ud655\uc131\uc744 \uac80\uc99d\ud569\ub2c8\ub2e4. <strong>Back Translation<\/strong><\/p>\n\n\n\n<p>\ub137\uc9f8, \uc5ec\ub7ec \uc5b8\uc5b4 \ubc84\uc804 \uc0ac\uc774\uc5d0 \ubd88\uc77c\uce58\uac00 \uc5c6\ub3c4\ub85d, \ud544\uc694 \uc2dc \ubb38\uc7a5\uc744 \uc218\uc815\u00b7\ubcf4\uc644\ud558\uc5ec \uc5b8\uc5b4\uac04 \uc77c\uad00\uc131\uc744 \ud655\ubcf4\ud569\ub2c8\ub2e4. <strong>Harmonization<\/strong><\/p>\n\n\n\n<p>\ub2e4\uc12f\uc9f8, \ub370\uc774\ud130 \uc785\ub825 \ub4f1\uc744 \uc704\ud55c \ub9c8\uc774\uadf8\ub808\uc774\uc158\uc744 \uc218\ud589\ud569\ub2c8\ub2e4. \ubc88\uc5ed\ub41c \ub0b4\uc6a9\uc744 \ub370\uc774\ud130 \uc218\uc9d1\uc774\ub098 \uad00\ub9ac\uc5d0 \uc801\ud569\ud55c \ub2e4\ub978 \ud50c\ub7ab\ud3fc\uc774\ub098 \ud615\uc2dd\uc73c\ub85c \uc801\ud569\ud558\uac8c \uc870\uc815\ud569\ub2c8\ub2e4. <strong>Migration<\/strong><\/p>\n\n\n\n<p>\uc5ec\uc12f\uc9f8, \uc804\uc790 \ud50c\ub7ab\ud3fc\uc5d0\uc11c \ubb38\uc11c\uc758 \uc2dc\uac01\uc801 \ud45c\ud604\uc774 \uc801\uc808\ud55c\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. <strong>Screenshot Review<\/strong><\/p>\n\n\n\n<p>\uc77c\uacf1\uc9f8, \uc2e4\uc81c \uc0ac\uc6a9\uc790 \uc778\ud130\ubdf0 \ub4f1\uc744 \ud1b5\ud574 \ubb38\ud654 \uc801\ud569\uc131\uc744 \ud655\uc778\ud569\ub2c8\ub2e4. \uc5b8\uc5b4 \uac80\uc99d \ub2e8\uacc4 \uc911 \uac00\uc7a5 \uc911\uc694\ud55c \ub2e8\uacc4\ub85c \ub300\uc0c1 \uc5b8\uc5b4\ub97c \ub300\ud45c\ud558\ub294 \uc18c\uaddc\ubaa8 \uadf8\ub8f9\uc5d0 \ud658\uc790 \ub300\uba74 \ub3c4\uad6c (\uc608: COA) \ub97c \ud14c\uc2a4\ud2b8\ud558\ub294 \uacfc\uc815\uc785\ub2c8\ub2e4. <strong>Cognitive Debriefing<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uacb0\ub860\">\uacb0\ub860<\/h3>\n\n\n\n<p>\uc694\uc57d\ud558\uc790\uba74, \uc5b8\uc5b4 \uac80\uc99d\uc740 \uc784\uc0c1 \uc2dc\ud5d8\uc758 \uc131\uacf5\uacfc \ub370\uc774\ud130\uc758 \uc2e0\ub8b0\uc131\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \ud544\uc218\uc801\uc778 \ubc88\uc5ed \uacfc\uc815\uc785\ub2c8\ub2e4. \uc5c4\uaca9\ud55c \uac80\uc99d \ud504\ub85c\uc138\uc2a4\ub97c \ud1b5\ud574 \ubb38\ud654\uc801\uc73c\ub85c \uc801\ud569\ud558\uace0 \ubb38\ub9e5\uc774 \uc815\ud655\ud55c \ubc88\uc5ed\uc744 \ub2ec\uc131\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub97c \ubc14\ud0d5\uc73c\ub85c \uc784\uc0c1 \ub370\uc774\ud130\uc640 \uc5f0\uad6c \uacb0\uacfc\uc758 \ud488\uc9c8\uc774 \ud5a5\uc0c1\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \uc5b8\uc5b4 \uac80\uc99d \uc791\uc5c5\uc5d0 \uc815\ud1b5\ud55c \uc804\ubb38 \ubc88\uc5ed\uac00\ub4e4\uc774 \uc788\uc2b5\ub2c8\ub2e4. \ub2e4\uc591\ud55c \uc9c0\uc5ed \uc5b8\uc5b4\ub85c, \uae00\ub85c\ubc8c \ub124\ud2b8\uc6cc\ud06c\ub97c \uae30\ubc18\uc73c\ub85c \uc815\ud655\ud558\uace0 \uc2e0\uc18d\ud55c \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc758\ub8cc \ubc0f \ubc14\uc774\uc624 \ubb38\uc11c \ubc88\uc5ed\uc744 \uc6d0\ud558\uc2dc\uba74 \ud55c\uc0d8\uae00\ub85c\ubc8c\ub85c \ubb38\uc758\ud574 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