{"id":718,"date":"2021-09-21T10:13:18","date_gmt":"2021-09-21T01:13:18","guid":{"rendered":"http:\/\/incrom.kir.jp\/bridging.jp\/test\/test.heishinkai.com\/?p=718"},"modified":"2025-07-16T12:12:53","modified_gmt":"2025-07-16T03:12:53","slug":"pattern_c","status":"publish","type":"post","link":"http:\/\/incrom.kir.jp\/bridging.jp\/test\/test.heishinkai.com\/procedure\/pattern_c\/","title":{"rendered":"C\uff0eAgatha \u3092\u4f7f\u7528\u3057\u306a\u3044\u304c\u3001\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u30fbIRB \u9593\u3067\u306e Agatha \u306e\u4f7f\u7528\u3092\u4e86\u627f\u3059\u308b"},"content":{"rendered":"

\uff11\uff0e\u5be9\u67fb\u8cc7\u6599\u306e\u63d0\u51fa\u306b\u3064\u3044\u3066<\/h3>\n

C-1\uff0e\u521d\u56de\u5be9\u67fb\u624b\u7d9a\u304d\u306b\u3064\u3044\u3066<\/span><\/b>
\n\u521d\u56de\u5be9\u67fb\u3092\u884c\u3046IRB\u958b\u50ac\u306e10\u65e5\u524d\u307e\u3067\u306b\u3001\u300c\u6cbb\u9a13\u4f9d\u983c\u66f8\uff08\u66f8\u5f0f3\uff09\u300d\u3092\u4f5c\u6210\u3057\u3001\u6cbb\u9a13\u4e8b\u52d9\u5c40\u3078\u3054\u63d0\u51fa\u304f\u3060\u3055\u3044\u3002
\n\u203b\u8cc7\u6599\u7de0\u5207\u65e5\u53b3\u5b88\u3067\u304a\u9858\u3044\u3057\u307e\u3059\u3002\u4e0d\u6e2c\u306e\u4e8b\u614b\u7b49\u306b\u3088\u308a\u3084\u3080\u3092\u5f97\u305a\u9045\u308c\u308b\u5834\u5408\u306f\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002
\n\"<\/a>
\n\"<\/a><\/p>\n

C-2\uff0e\u5be9\u67fb\u8cc7\u6599<\/span><\/b>
\n\u3053\u3061\u3089\u3067\u6e96\u5099\u4f5c\u6210\u3059\u308b\u8cc7\u6599\u306f\u3001\u4e8b\u524d\u306b\u96fb\u5b50\u5a92\u4f53\u306b\u3066\u9001\u4ed8\u3057\u307e\u3059\u3002<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u8cc7\u6599\u540d<\/td>\n\u88dc\u8db3\u8aac\u660e<\/td>\n<\/tr>\n
\u2460\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8<\/td>\n<\/td>\n<\/tr>\n
\u2461\u6cbb\u9a13\u85ac\u6982\u8981\u66f8\u307e\u305f\u306f\u6dfb\u4ed8\u6587\u66f8<\/td>\n<\/td>\n<\/tr>\n
\u2462\u75c7\u4f8b\u5831\u544a\u66f8\u306e\u898b\u672c<\/td>\n\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306b\u304a\u3044\u3066\u8a18\u8f09\u4e8b\u9805\u304c\u5341\u5206\u306b\u8aad\u307f\u53d6\u308c\u308b\u5834\u5408\u306f\u4e0d\u8981<\/td>\n<\/tr>\n
\u2463\u8aac\u660e\u6587\u66f8\u30fb\u540c\u610f\u6587\u66f8<\/td>\n\u4f9d\u983c\u8005\u6848\u3092\u3054\u63d0\u4f9b\u3044\u305f\u3060\u304d\u533b\u7642\u6a5f\u95a2\u306b\u3066\u65bd\u8a2d\u7248\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/td>\n<\/tr>\n
\u2464\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u5c65\u6b74\u66f8<\/td>\n\u533b\u7642\u6a5f\u95a2\u306b\u3066\u6e96\u5099\u4f5c\u6210<\/td>\n<\/tr>\n
\u2465\u6cbb\u9a13\u5206\u62c5\u533b\u5e2b\u306e\u6c0f\u540d\u3092\u8a18\u8f09\u3057\u305f\u6587\u66f8<\/td>\n\u533b\u7642\u6a5f\u95a2\u306b\u3066\u6e96\u5099\u4f5c\u6210<\/td>\n<\/tr>\n
\u2466\u88ab\u9a13\u8005\u3078\u306e\u652f\u6255\u3044\u306b\u95a2\u3059\u308b\u8cc7\u6599<\/td>\n\u533b\u7642\u6a5f\u95a2\u306b\u3066\u6e96\u5099\u4f5c\u6210<\/td>\n<\/tr>\n
\u2467\u88ab\u9a13\u8005\u306e\u5065\u5eb7\u88ab\u5bb3\u306b\u5bfe\u3059\u308b\u88dc\u511f\u306b\u95a2\u3059\u308b\u8cc7\u6599
\n\u30fb\u4ed8\u4fdd\u8a3c\u660e\u66f8\uff08\u5199\uff09
\n\u30fb\u533b\u7642\u6a5f\u95a2\u7528\u88dc\u511f\u5236\u5ea6\u306e\u6982\u8981
\n\u30fb\u88ab\u9a13\u8005\u7528\u88dc\u511f\u5236\u5ea6\u306e\u6982\u8981<\/td>\n		\u66f8\u5f0f\u4e0d\u554f
\n\u88dc\u511f\u5236\u5ea6\u306e\u6982\u8981\u306e\u5185\u5bb9\u306b\u3064\u3044\u3066\u306f\u3001\u4e8b\u524d\u306b\u78ba\u8a8d\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u305f\u3044\u306e\u3067\u65e9\u76ee\u306b\u96fb\u5b50\u5a92\u4f53\u306b\u3066\u3054\u63d0\u51fa\u304f\u3060\u3055\u3044\u3002<\/td>\n<\/tr>\n
\u2468\u88ab\u9a13\u8005\u52df\u96c6\u624b\u9806\uff08\u5e83\u544a\u7b49\uff09\u306b\u95a2\u3059\u308b\u8cc7\u6599<\/td>\n\u533b\u7642\u6a5f\u95a2\u306b\u3066\u6e96\u5099\u4f5c\u6210<\/td>\n<\/tr>\n
\u2469\u88ab\u9a13\u8005\u306e\u5b89\u5168\u6027\u306b\u4fc2\u308b\u8cc7\u6599<\/td>\n\u8a72\u5f53\u8cc7\u6599\u304c\u306a\u3044\u5834\u5408\u3042\u308b\u3044\u306f\u6cbb\u9a13\u85ac\u6982\u8981\u66f8\u306b\u542b\u307e\u308c\u308b\u5834\u5408\u306f\u7701\u7565\u53ef<\/td>\n<\/tr>\n
\u246a\u305d\u306e\u4ed6\uff08\u65e5\u8a8c\u30fb\u30a2\u30f3\u30b1\u30fc\u30c8\u7b49\uff09<\/td>\n\u8a72\u5f53\u8cc7\u6599\u304c\u306a\u3044\u5834\u5408\u306f\u7701\u7565\u53ef<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

C-3\uff0e\u5be9\u67fb\u8cc7\u6599\u306e\u63d0\u4f9b\u65b9\u6cd5\u30fb\u5fc5\u8981\u90e8\u6570\u306b\u3064\u3044\u3066<\/span><\/b>
\n\u3010IRB \u5be9\u67fb\u7528\uff08\u96fb\u5b50\u8cc7\u6599\u3001\u7d19\u8cc7\u6599\uff09\uff08\u5be9\u67fb\u8cc7\u6599\u2460\uff5e\u246a\uff09\u3011
\n\u30fb\u63d0\u4f9b\u65b9\u6cd5\uff1a\u30e1\u30fc\u30eb\u3082\u3057\u304f\u306f\u90f5\u9001
\n\u96fb\u5b50\u63d0\u4f9b\u304c\u53ef\u80fd\u306a\u8cc7\u6599\u306b\u3064\u3044\u3066\u306f\u3001\u30e1\u30fc\u30eb\u306b\u3066 PDF \u3067\u306e\u63d0\u4f9b\u3092\u3001\u96fb\u5b50\u63d0\u4f9b\u304c\u4e0d\u53ef\u80fd\u306a\u8cc7\u6599\u306b\u3064\u3044\u3066\u306f\u3001\u7d19\u5a92\u4f53\u3067\u306e\u63d0\u4f9b\u3092\u304a\u9858\u3044\u3044\u305f\u3057\u307e\u3059\u3002
\n\u30fb\u5fc5\u8981\u90e8\u6570\uff1a1 \u90e8\uff08\u96fb\u5b50\u63d0\u4f9b\u304c\u4e0d\u53ef\u80fd\u306a\u8cc7\u6599\u306e\u307f\uff09
\n\uff08\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u4e0d\u8981\u30fb\u30db\u30c1\u30ad\u30b9\u6b62\u3081\u306a\u3057\u30fb2 \u7a74\u306a\u3057\uff09<\/p>\n

\u3010IRB \u914d\u5e03\u7528\uff08\u7d19\u8cc7\u6599\uff09\uff08\u5be9\u67fb\u8cc7\u6599\u2460\u3068\u2463\uff09\u3011
\n\u2460\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306a\u3089\u3073\u306b\u2463\u8aac\u660e\u6587\u66f8\u30fb\u540c\u610f\u6587\u66f8\u306b\u3064\u3044\u3066\u306f\u7d19\u5a92\u4f53\u3067\u3082\u914d\u5e03\u3057\u307e\u3059\u306e\u3067\u3001\u5225\u9014\u7d19\u5a92\u4f53\u3067\u306e\u63d0\u4f9b\u3092\u304a\u9858\u3044\u3044\u305f\u3057\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u2460\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306b\u3064\u3044\u3066\u306f\u3001\u82f1\u8a9e\u7248\uff08\u3042\u308b\u5834\u5408\uff09\u53ca\u3073\u5225\u7d19\u3001\u5225\u518a\u7b49\u306f\u4e0d\u8981\u3067\u3059\u306e\u3067\u3001\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u672c\u4f53\u306e\u65e5\u672c\u8a9e\u7248\u306e\u307f\u3067\u69cb\u3044\u307e\u305b\u3093\u3002
\n\u30fb\u63d0\u4f9b\u65b9\u6cd5\uff1a\u90f5\u9001
\n\u30fb\u5fc5\u8981\u90e8\u6570\uff1a12 \u90e8\uff08\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u4e0d\u8981\u30fb\u30db\u30c1\u30ad\u30b9\u6b62\u3081\u3042\u308a\u30fb2 \u7a74\u3042\u308a\uff09<\/p>\n

\u3010\u4fdd\u7ba1\u7528\uff08\u7d19\u8cc7\u6599\uff09\uff08\u5be9\u67fb\u8cc7\u6599\u2460\uff5e\u246a\uff09\u3011
\n\u30fb\u63d0\u4f9b\u65b9\u6cd5\uff1a\u90f5\u9001
\n\u30fb\u5fc5\u8981\u90e8\u6570\uff1a\u5927\u962a\u6cbb\u9a13\u75c5\u9662\uff1a2\u90e8
\nOCROM\u30af\u30ea\u30cb\u30c3\u30af\uff1a2\u90e8
\nToCROM\u30af\u30ea\u30cb\u30c3\u30af\uff1a2\u90e8
\n\uff08\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u4e0d\u8981\u30fb\u30db\u30c1\u30ad\u30b9\u6b62\u3081\u3042\u308a\u30fb2\u7a74\u3042\u308a\uff09<\/p>\n

C-4\uff0e\u5be9\u67fb\u8cc7\u6599\u306e\u9001\u4ed8\u5148<\/span><\/b>
\n\u6cbb\u9a13\u4f9d\u983c\u65bd\u8a2d\u306e\u5404\u6cbb\u9a13\u4e8b\u52d9\u5c40\u9577\u5b9b\u306b\u3054\u9001\u4ed8\u304f\u3060\u3055\u3044\u3002
\n\u305f\u3060\u3057\u3001\u5e73\u5fc3\u4f1a 2 \u65bd\u8a2d\u4ee5\u4e0a\u3067\u4f9d\u983c\u3055\u308c\u308b\u5834\u5408\u306e IRB \u914d\u5e03\u7528\u7d19\u8cc7\u6599\u306b\u3064\u3044\u3066\u306f\u3001\u5927\u962a\u6cbb\u9a13\u75c5\u9662\u304c\u4f9d\u983c\u65bd\u8a2d\u306b\u542b\u307e\u308c\u308b\u5834\u5408\u306f\u5927\u962a\u6cbb\u9a13\u75c5\u9662\u306e\u6cbb\u9a13\u4e8b\u52d9\u5c40\u9577\u5b9b\u306b\u3001OCROM \u30af\u30ea\u30cb\u30c3\u30af\u3068 ToCROM \u30af\u30ea\u30cb\u30c3\u30af\u306b\u4f9d\u983c\u3055\u308c\u308b\u5834\u5408\u306f\u3001OCROM \u30af\u30ea\u30cb\u30c3\u30af\u306e\u6cbb\u9a13\u4e8b\u52d9\u5c40\u9577\u5b9b\u306b\u3054\u9001\u4ed8\u304f\u3060\u3055\u3044\u3002<\/p>\n

C-5\uff0e\u5be9\u67fb\u7d50\u679c\u5831\u544a\u306b\u3064\u3044\u3066<\/span><\/b>
\nIRB \u958b\u50ac\u7fcc\u65e5\u3001\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\u304c\u300c\u6cbb\u9a13\u5be9\u67fb\u7d50\u679c\u901a\u77e5\u66f8\uff08\u66f8\u5f0f 5\uff09\u300d\u3092\u4f5c\u6210\u3057\u3001\u30e1\u30fc\u30eb\u306b\u3066\u3054\u9023\u7d61\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n

\u300c\u4fee\u6b63\u306e\u4e0a\u3001\u627f\u8a8d\u6642\u300d\u306e\u5bfe\u5fdc\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002
\n\u2460IRB\u306e\u6307\u793a\u306e\u3082\u3068\u95a2\u9023\u6587\u66f8\u3092\u4fee\u6b63\u3059\u308b
\n\u2461\u300c\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u7b49\u4fee\u6b63\u5831\u544a\u66f8\uff08\u66f8\u5f0f6\uff09\u300d\u3092\u4f5c\u6210\u3059\u308b
\n\u2462\u6cbb\u9a13\u4e8b\u52d9\u5c40\u3078\u30e1\u30fc\u30eb\u306b\u3066\u66f8\u5f0f6\u304a\u3088\u3073\u95a2\u9023\u6587\u66f8\u3092\u9001\u4ed8
\n\u2463\u6cbb\u9a13\u4e8b\u52d9\u5c40\u306f\u3001\u66f8\u5f0f6\u3068\u95a2\u9023\u6587\u66f8\u3092\u78ba\u8a8d\u3059\u308b\uff08\u4fee\u6b63\u5185\u5bb9\u306e\u78ba\u8a8d\u5f8c\u306b\u6cbb\u9a13\u5951\u7d04\u304c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\uff09
\n\u2464IRB\u4e8b\u52d9\u5c40\u3078\u63d0\u51fa\u3057\u3001\u6b21\u56de\u306eIRB\u306b\u3066\u5831\u544a\u624b\u914d\u3092\u884c\u3046
\n\u305f\u3060\u3057\u3001\u8aac\u660e\u6587\u66f8\u306e\u4fee\u6b63\u6307\u793a\u306e\u307f\u306e\u5834\u5408\u306f\u3001\u3059\u3079\u3066\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u3067\u5bfe\u5fdc\u3057\u307e\u3059\u3002<\/p>\n

C-6\uff0e\u5be9\u8b70\u8a18\u9332\u306b\u3064\u3044\u3066<\/span><\/b>
\nIRB\u4e8b\u52d9\u5c40\u306b\u3066\u4f5c\u6210\u3055\u308c\u305f\u5be9\u8b70\u8a18\u9332\u306f\u3001FIX\u5f8c\u306b\u533b\u7642\u6a5f\u95a2\u306e\u5fc5\u9808\u6587\u66f8\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u7ba1\u3057\u307e\u3059\u3002<\/p>\n

\uff12\uff0eIRB\u8aac\u660e\u7528\u8cc7\u6599\u306b\u3064\u3044\u3066<\/h3>\n

IRB\u5f53\u65e5\u306b\u8aac\u660e\u306b\u7528\u3044\u308b\u30d1\u30ef\u30fc\u30dd\u30a4\u30f3\u30c8\u30d5\u30a1\u30a4\u30eb\u7b49\u3092\u4f5c\u6210\u306e\u4e0a\u3001\u6cbb\u9a13\u4e8b\u52d9\u5c40\u5b9b\u3078\u4e8b\u524d\u306b\u30e1\u30fc\u30eb\u3067\u304a\u9001\u308a\u304f\u3060\u3055\u3044\u3002\u5be9\u8b70\u6642\u306e\u8aac\u660e\u306f\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u304c\u884c\u3044\u307e\u3059\u3002<\/p>\n

\uff13\uff0e\u958b\u50ac\u65e5\u5f53\u65e5\u306b\u3064\u3044\u3066<\/h3>\n

\u6cbb\u9a13\u4f9d\u983c\u8005\u306eIRB\u51fa\u5e2d\u306b\u3064\u3044\u3066\u306f\u3001\u88ab\u9a13\u85ac\u306e\u985e\u85ac\u304c\u306a\u3044First In Human\uff08FIH\uff09\u8a66\u9a13\u306e\u521d\u56deIRB\u306f\u3001\u539f\u5247\u51fa\u5e2d\u3092\u304a\u9858\u3044\u3057\u3066\u304a\u308a\u307e\u3059\u3002\u305d\u308c\u4ee5\u5916\u306e\u5834\u5408\u306f\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u8981\u671b\u304c\u306a\u3044\u9650\u308a\u306f\u4e0d\u8981\u3067\u3059\u304c\u3001\u5be9\u8b70\u4e2d\u306b\u51fa\u3055\u308c\u305f\u59d4\u54e1\u304b\u3089\u306e\u7591\u7fa9\u306b\u3064\u3044\u3066\u304a\u554f\u3044\u5408\u308f\u305b\u3059\u308b\u5834\u5408\u304c\u3054\u3056\u3044\u307e\u3059\u306e\u3067\u3001\u521d\u56deIRB\u306e\u307f\u5be9\u8b70\u4e2d\u306b\u96fb\u8a71\u3067\u9023\u7d61\u304c\u53d6\u308c\u308b\u72b6\u6cc1\u306b\u3057\u3066\u3044\u305f\u3060\u304f\u3088\u3046\u306b\u304a\u9858\u3044\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n

\"\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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