{"id":294,"date":"2016-01-07T15:47:30","date_gmt":"2016-01-07T06:47:30","guid":{"rendered":"http:\/\/blog.tedama.co.jp\/?p=294"},"modified":"2016-01-07T23:10:32","modified_gmt":"2016-01-07T14:10:32","slug":"1240%e3%81%a8%e3%81%84%e3%81%86%e8%a1%9d%e6%92%83%e6%97%a5%e6%9c%ac%e3%81%ae%e6%b2%bb%e9%a8%93%e5%a7%94%e5%93%a1%e4%bc%9a%e6%95%b0","status":"publish","type":"post","link":"https:\/\/site.tedama.co.jp\/?p=294","title":{"rendered":"1240\u3068\u3044\u3046\u885d\u6483\u2026\u65e5\u672c\u306e\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u6570"},"content":{"rendered":"

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1240<\/span><\/strong><\/span>\u3042\u308a\u307e\u3059\u3002\u3061\u306a\u307f\u306b\u30aa\u30e9\u30f3\u30c0\u306f23\u3001\u30c9\u30a4\u30c4\u306f53\u3001\u30d5\u30e9\u30f3\u30b9\u306f39\u2026\u3068\u3044\u3063\u305f\u5177\u5408\u3067\u3059\u3002Wikipedia\u5148\u751f\u3092\u53c2\u8003\u306b\u4eba\u53e3\u8abf\u6574\u3057\u3066\u307f\u3066\u3082\u3001\u65e5\u672c\u306e\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u6570\u304c\u51c4\u3044\u3053\u3068\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3059\u3002\u4f55\u6545\u3001\u3053\u306e\u3088\u3046\u306a\u3053\u3068\u304c\u8d77\u304d\u3066\u3044\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/p>\n

\u30aa\u30e9\u30f3\u30c0\u3082\u6614\u306f\u305f\u304f\u3055\u3093\u3042\u3063\u305f<\/h2>\n

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\u7c21\u5358\u306b\u8a8d\u5b9a\u3092\u53d6\u3089\u305b\u306a\u3044<\/h2>\n

\u65e5\u672c\u306e\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u306e\u69cb\u6210\u306f\u7701\u4ee4GCP\u7b2c28\u6761\u306b\u3066\u4e0b\u8a18\u306e\u901a\u308a\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\uff1a<\/p>\n

    \n
  1. \u6cbb\u9a13\u306b\u3064\u3044\u3066\u502b\u7406\u7684\u53ca\u3073\u79d1\u5b66\u7684\u89b3\u70b9\u304b\u3089\u5341\u5206\u306b\u5be9\u8b70\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u308b\u3053\u3068\u3002<\/li>\n
  2. \uff15\u540d\u4ee5\u4e0a\u306e\u59d4\u54e1\u304b\u3089\u306a\u308b\u3053\u3068\u3002<\/li>\n
  3. \u59d4\u54e1\u306e\u3046\u3061\u3001\u533b\u5b66\u3001\u6b6f\u5b66\u3001\u85ac\u5b66\u305d\u306e\u4ed6\u306e\u533b\u7642\u53c8\u306f\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308b\u5c02\u9580\u7684\u77e5\u8b58\u3092\u6709 \u3059\u308b\u8005\u4ee5\u5916\u306e\u8005\uff08\u6b21\u53f7\u53ca\u3073\u7b2c\uff15\u53f7\u306e\u898f\u5b9a\u306b\u3088\u308a\u59d4\u54e1\u306b\u52a0\u3048\u3089\u308c\u3066\u3044\u308b\u8005\u3092\u9664\u304f\u3002\uff09\u304c\u52a0 \u3048\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3002<\/li>\n
  4. \u59d4\u54e1\u306e\u3046\u3061\u3001\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u3068\u5229\u5bb3\u95a2\u4fc2\u3092\u6709\u3057\u306a\u3044\u8005\u304c\u52a0\u3048\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3002<\/li>\n
  5. \u59d4\u54e1\u306e\u3046\u3061\u3001\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u306e\u8a2d\u7f6e\u8005\u3068\u5229\u5bb3\u95a2\u4fc2\u3092\u6709\u3057\u306a\u3044\u8005\u304c\u52a0\u3048\u3089\u308c\u3066\u3044\u308b\u3053 \u3068\u3002<\/li>\n<\/ol>\n

    \u5bfe\u3057\u3066\u3001\u30aa\u30e9\u30f3\u30c0\u306eWMO\u7b2c16\u6761\u3067\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u502b\u7406\u59d4\u54e1\u4f1a\u306e\u69cb\u6210\u306f\u4e0b\u8a18\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n

      \n
    1. one physician<\/li>\n
    2. persons with expertise in:\u00a0the law,\u00a0research methodology,\u00a0ethics<\/li>\n
    3. a person charged with the task of examining protocols specifically from the subject\u2019s point of view<\/li>\n
    4. in the case of the review of clinical trials involving medicinal products, persons with expertise in:\u00a0pharmacy,\u00a0clinical pharmacology<\/li>\n<\/ol>\n

      \u8868\u306b\u307e\u3068\u3081\u3066\u307f\u308b\u3068\u3001\u30aa\u30e9\u30f3\u30c0\u306e\u65b9\u304c\u8981\u4ef6\u304c\u53b3\u683c\u306b\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
      \u5c02\u9580<\/strong><\/td>\n\u65e5\u672c<\/strong><\/td>\n\u30aa\u30e9\u30f3\u30c0<\/strong><\/td>\n<\/tr>\n
      \u533b\u5b66<\/td>\n\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u6cd5\u5b66<\/td>\n\u4e0d\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u751f\u7269\u7d71\u8a08<\/td>\n\u4e0d\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u502b\u7406<\/td>\n\u4e0d\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u85ac\u5b66<\/td>\n\u4e0d\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u85ac\u7406\u5b66<\/td>\n\u4e0d\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u975e\u5c02\u9580\u59d4\u54e1<\/td>\n\u8981<\/td>\n\u8981<\/td>\n<\/tr>\n
      \u5916\u90e8\u59d4\u54e1<\/td>\n\u8981<\/td>\n\u4e0d\u8981<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      \u5c11\u3057\u89e3\u8aac\u3059\u308b\u3068\u3001Research Methodology\u306f\u5b9f\u969b\u306b\u306f\u300c\u751f\u7269\u7d71\u8a08\u300d\u3092\u6307\u3057\u3066\u3044\u308b\u69d8\u3067\u3001Ethics\u306e\u5c02\u9580\u5bb6\u306f\u795e\u5b66\u3084\u54f2\u5b66\u306a\u3069\u306e\u5c02\u9580\u5bb6\u304c\u591a\u3044\u3068\u306e\u3053\u3068\u3067\u3059\u3002\u5916\u90e8\u59d4\u54e1\u8981\u3089\u306a\u3044\u306e\uff1f\u3068\u601d\u308f\u308c\u308b\u304b\u3082\u77e5\u308c\u307e\u305b\u3093\u304c\u3001\u65e5\u672c\u306e\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u3068\u7570\u306a\u308a\u3001\u8a2d\u7f6e\u306f\u75c5\u9662\u9577\u3067\u306f\u306a\u304fCCMO\u306e\u592a\u9f13\u5224\u3092\u3082\u3063\u3066\u884c\u308f\u308c\u308b\u3053\u3068\u3001\u305d\u3082\u305d\u3082\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u3068\u306f\u300c\u72ec\u7acb\u300d\u3057\u305f\u59d4\u54e1\u4f1a\u3067\u3042\u308b\u3053\u3068\u304c\u5927\u524d\u63d0\u3067\u3042\u308b\u3053\u3068\u3001\u975e\u5c02\u9580\u54e1\u304c\u5916\u90e8\u306e\u3082\u306e\u3067\u3042\u308b\u306e\u304c\u591a\u3044\u3053\u3068\u304b\u3089\u3001\u3042\u307e\u308a\u5fc5\u8981\u6027\u306f\u611f\u3058\u3066\u3044\u306a\u3044\u305d\u3046\u3067\u3059\u3002\u81ea\u6d44\u4f5c\u7528\u304c\u5145\u5206\u306b\u3042\u308b\u3060\u308d\u3046\u3068\u3044\u3046\u4e00\u822c\u8a8d\u8b58\u304c\u3042\u308b\u3068\u601d\u308f\u308c\u307e\u3059\u3002\u3053\u3053\u306f\u3001\u56fd\u6c11\u6027\u306e\u9055\u3044\u3067\u3057\u3087\u3046\u304b\u3002\u305d\u308c\u306b\u3057\u3066\u3082\u3001\u3053\u3093\u306a\u306b\u8a2d\u7f6e\u6761\u4ef6\u3092\u53b3\u3057\u304f\u3057\u3066\u3001\u56fd\u5185\u306e\u6cbb\u9a13\u306e\u5be9\u67fb\u3092\u3059\u3079\u3066\u634c\u3051\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u3053\u308c\u306b\u306f\u3061\u3087\u3063\u3068\u3057\u305f\u5de5\u592b\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

      \u591a\u65bd\u8a2d\u5171\u540c\u7814\u7a76\u3067\u3082\u4e00\u304b\u6240\u3067\u5be9\u67fb<\/h2>\n

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