{"id":2075,"date":"2021-05-27T08:53:59","date_gmt":"2021-05-26T23:53:59","guid":{"rendered":"http:\/\/snsclub.urayasucitizens.net\/mousebuddies\/?p=2075"},"modified":"2021-05-27T08:55:02","modified_gmt":"2021-05-26T23:55:02","slug":"%e3%83%95%e3%82%a1%e3%82%a4%e3%82%b6%e3%83%bc%e6%b2%bb%e9%a8%93%e3%80%80%e3%83%97%e3%83%ad%e3%83%88%e3%82%b3%e3%83%ab%e3%81%ab%e8%a6%8b%e3%82%8b%e4%b8%8d%e5%8f%af%e6%80%9d%e8%ad%b0","status":"publish","type":"post","link":"https:\/\/snsclub.urayasucitizens.net\/mousebuddies\/2021\/05\/27\/%e3%83%95%e3%82%a1%e3%82%a4%e3%82%b6%e3%83%bc%e6%b2%bb%e9%a8%93%e3%80%80%e3%83%97%e3%83%ad%e3%83%88%e3%82%b3%e3%83%ab%e3%81%ab%e8%a6%8b%e3%82%8b%e4%b8%8d%e5%8f%af%e6%80%9d%e8%ad%b0\/","title":{"rendered":"\u30d5\u30a1\u30a4\u30b6\u30fc\u6cbb\u9a13\u3000\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u898b\u308b\u4e0d\u53ef\u601d\u8b70"},"content":{"rendered":"
\n
\"\"<\/a>
\u3010\u30cb\u30e5\u30fc\u30e8\u30fc\u30af\uff1d\u6749\u85e4\u8cb4\u6d69\u3011\u7c73\u56fd\u5185\u3067\u65b0\u578b\u30b3\u30ed\u30ca\u30ef\u30af\u30c1\u30f3\u306e\u63a5\u7a2e\u304c\u9032\u3080\u4e00\u65b9\u3001\u5357\u90e8\u30d5\u30ed\u30ea\u30c0\u5dde\u30de\u30a4\u30a2\u30df\u306e\u79c1\u7acb\u5b66\u6821\u304c\u3001\u63a5\u7a2e\u3057\u305f\u6559\u5e2b\u3092\u751f\u5f92\u306b\u63a5\u89e6\u3055\u305b\u306a\u3044\u65b9\u91dd\u3092\u6253\u3061\u51fa\u3057\u3066\u7269\u8b70\u3092\u91b8\u3057\u3066\u3044\u308b\u3002<\/figcaption><\/figure>\n

\u30de\u30f3\u30dc\u30a6\u306b\u81ea\u7c9b\u3092\u5f37\u5236\u3055\u305b\u3066\u3082\u3001\u4e00\u5411\u306b\u76ee\u306b\u898b\u3048\u308b\u6210\u679c\u304c\u51fa\u3066\u3053\u306a\u3044\u3068\u3044\u3046\u73fe\u72b6\u306e\u4e8b\u5b9f\u304c\u3042\u308b\u3002<\/span><\/p>\n<\/div>\n

\u79d1\u5b66\u7684\u6839\u62e0\u306b\u57fa\u3064\u304f\u5408\u7406\u7684\u306a\u653f\u7b56\u306a\u3089\u3070\u76ee\u306b\u898b\u3048\u305f\u6210\u679c\u304c\u51fa\u3066\u5f53\u7136\u306a\u7b48\u3060\u304c\u51fa\u3066\u3053\u306a\u3044\u306e\u306f\u4f55\u6545\u304b\uff1f<\/span><\/div>\n
\u653f\u7b56\u304c\u8aa4\u3063\u3066\u3044\u306a\u304c\u3089\u3001\u540c\u3058\u65b9\u7b56\u3092\u63a1\u308a\u7d9a\u3051\u308b\u6545\u306b\u6210\u679c\u304c\u51fa\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u306b\u306a\u308d\u3046\u3002\u3001\u653f\u5e9c\u304c\u63a1\u3063\u3066\u304d\u305f\u65b9\u7b56\u306f\u3001\u611f\u67d3\u540c\u5b9a\u624b\u6cd5\u305d\u306e\u3082\u306e\u304c\u6b63\u3057\u3044\u3068\u306e\u4e88\u65ad\u306e\u4e0a\u306b\u6210\u308a\u7acb\u3063\u3066\u3044\u308b\u3002<\/span><\/div>\n
\u305d\u306e\u5927\u304d\u306a\u554f\u984c\u70b9\u306f\uff12\u70b9\u5728\u308b\u4e00\u3064\u306f\u907a\u4f1d\u5b50\u5de5\u5b66\u306b\u3088\u308bPCR\u691c\u67fb\u7d50\u679c\u306e\u967d\u6027\u3092\u611f\u67d3\u3068\u8a00\u3044\u63db\u3048\u3066\u554f\u984c\u306b\u5bfe\u51e6\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u70b9\u3002\uff12\u70b9\u76ee\u306f\u3001\u305d\u306ePCR\u691c\u67fb\u6cd5\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u30d6\u30e9\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u306e\u307e\u307e\u904b\u7528\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3002\u3053\u306e\u70b9\u306b\u3064\u3044\u3066\u306f\u5897\u5e45ct\u5024\u306e\u554f\u984c<\/span><\/a><\/span>\u3068\u3057\u3066\u53d6\u308a\u4e0a\u3052\u3066\u304d\u305f\u3002\u624b\u6280\u306e\u512a\u52a3\u306f\u5225\u306b\u3057\u3066\u3002\u305d\u3057\u3066\u3001\u73fe\u5b9f\u306f\u89e3\u6c7a\u306e\u9053\u3092\u898b\u3044\u3060\u3059\u3069\u3053\u308d\u304b\u3001\u81ea\u7c9b\u306b\u65e7\u614b\u4ee5\u524d\u306e\u7dca\u6025\u4e8b\u614b\u306e\u679c\u3066\u3057\u306a\u3044\u7d99\u7d9a\u3068\u3044\u3046\u3053\u3068\u4ee5\u5916\u306e<\/span>\u8ff7\u8d70\u3092\u7d9a\u3051\u3066\u3044\u308b\u3002<\/span><\/div>\n
<\/div>\n
\u4eca\u56de\u306e\u3088\u3046\u306a\u3001\u672a\u77e5\u306e\u79d1\u5b66\u5206\u91ce\u306b\u304a\u3044\u3066\u3001\u533b\u5b66\u306e\u8a3a\u65ad\u6cd5\u304c\u672a\u5b8c\u6210\u306a\u3068\u3053\u308d\u306b\u3001\u3042\u305f\u304b\u3082\u30ef\u30af\u30c1\u30f3\u304c\u6551\u4e16\u4e3b\u306e\u3054\u3068\u304f\u55a7\u4f1d\u3055\u308c\u3001\u56fd\u6c11\u306e\u7121\u77e5\u3092\u9006\u624b\u306b\u3068\u308a\u3001\u533b\u5e2b\u306e\u56e3\u4f53\u306b\u3088\u308b\u5f37\u3044\u5371\u60e7\u611f\u3068\u6279\u5224\u304c\u7d9a\u304f\u4e2d\u3001\u7279\u5b9a\u306e\u533b\u85ac\u54c1\u696d\u754c\u304c\u653f\u5e9c\u3092\u5dfb\u304d\u8fbc\u3093\u3067\u3001\u5f37\u5f15\u306a\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u51e6\u6cd5\u304c\u63a1\u3089\u308c\u3066\u3044\u308b\u3068\u3044\u3046\u3068\u3053\u308d\u306b\u554f\u984c\u306e\u6839\u304c\u3042\u308b\u3002<\/span><\/div>\n
<\/div>\n
\u907a\u4f1d\u5b50\u89e3\u6790\u306b\u3088\u308b\u75c5\u6c17\u306e\u8a3a\u65ad\u306f\u3001\u5b9f\u969b\u306e\u691c\u51fa\u30a6\u30a4\u30eb\u30b9\u91cf\u306e\u5927\u304d\u3055\u3092\u8003\u616e\u305b\u305a\uff08\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u3057\u3066\u306ect\u5024\u306e\u6271\u3044\u306b\u3088\u3063\u3066\u5927\u5e45\u306a\u64ec\u967d\u6027\u3092\u4f34\u3046\uff09\u3001\u5927\u91cf\u306e\u201d\u611f\u67d3\u8005\u201d\u3092\u6f14\u51fa\u3057\u3001\u305d\u308c\u306b\u57fa\u3065\u3044\u3066\u7dca\u6025\u4f7f\u7528\u306e\u30ef\u30af\u30c1\u30f3\u306b\u8d70\u308b\u4eca\u3001\u5982\u4f55\u306b\u305d\u306e\u30ef\u30af\u30c1\u30f3\u304c\u4e0d\u660e\u77ad\u306a\u3082\u306e\u3067\u3042\u308b\u304b\u306e\u4e00\u7aef\u3092\u898b\u3066\u307f\u305f\u3044\u3002<\/span><\/div>\n
<\/div>\n
\u30ef\u30af\u30c1\u30f3\u958b\u767a\u4f1a\u793e\u306e\u6cbb\u9a13\u6587\u66f8\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u4f55\u304c\u66f8\u304b\u308c\u3066\u3044\u308b\u304b\u3001\u63a5\u7a2e\u8005\u304c\u77e5\u3089\u306a\u3044\u5074\u9762\u3092\u5207\u308a\u51fa\u3057\u3066\u307f\u305f\u3002\u3042\u308b\u30b5\u30a4\u30c8<\/a>\u3067\u306f\u3001<\/span><\/span><\/span>\u30ef\u30af\u30c1\u30f3\u3053\u305d\u304c\u611f\u67d3\u6e90\u3068\u3044\u3044\u3001<\/span>\u300c\u30ef\u30af\u30c1\u30f3\u63a5\u7a2e\u8005\u304c\u5468\u56f2\u306b\u75c5\u6c17\u3092\u307e\u304d\u6563\u3089\u3059\u300d<\/span><\/span>\u3068\u3044\u3046\u3002\u3053\u308c\u306f\u3001\u5168\u304f\u6839\u62e0\u306e\u7121\u3044\u3082\u306e\u3067\u3082\u7121\u304f\u3001\u305f\u3057\u304b\u306b\u30d5\u30a1\u30a4\u30b6\u30fc\u793e\u306e\u6cbb\u9a13\u6587\u66f8\u306b\u305d\u308c\u3089\u3057\u3044\u6839\u62e0\u304c\u66f8\u304b\u308c\u3066\u3042\u308b\u3002\u5358\u7d14\u306b<\/span>\u9670\u8b00\u8ad6<\/a><\/span>\u3068\u3057\u3066\u7247\u4ed8\u3051\u308b\u306e\u3067\u306f\u7121\u304f\u3001\u51b7\u9759\u306b\u898b\u3066\u9802\u304d\u305f\u3044\u3002<\/span><\/div>\n
<\/div>\n
\u3068\u3044\u3046\u3053\u3068\u3067\u6587\u66f8\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/a>\u3057\u3066\u307f\u305f\u3002<\/span><\/div>\n
<\/div>\n
\u30d5\u30a1\u30a4\u30b6\u30fcRNA\u3000\u30d7\u30ed\u30c8\u30b3\u30eb<\/a><\/span>\u306f\u3001\u9577\u6587\u306e\u8cc7\u6599\u3067\u3059\u3002\u6b86\u3069\u306e\u533b\u7642\u5f93\u4e8b\u8005\u306f\u305d\u306e\u5b58\u5728\u3059\u3089\u77e5\u3089\u306a\u3044\u306f\u305a\u3002<\/span><\/div>\n
<\/div>\n
\u6587\u66f8\u306e<\/span>67\u30da\u30fc\u30b8\u76ee\u3002<\/span><\/div>\n
8.3.5. \u598a\u5a20\u4e2d\u307e\u305f\u306f\u6388\u4e73\u4e2d\u306e\u66dd\u9732\u3001\u304a\u3088\u3073\u8077\u696d\u7684\u66dd\u9732<\/span><\/span><\/strong>
\nExposure to the study intervention under study during pregnancy or breastfeeding and <\/span>occupational exposure are reportable to Pfizer Safety within 24 hours of investigator <\/span>awareness.<\/span><\/div>\n
\u598a\u5a20\u4e2d\u307e\u305f\u306f\u6388\u4e73\u4e2d\u306e\u6cbb\u9a13\u3067\u306e\u66dd\u9732\u304a\u3088\u3073<\/span>\u8077\u696d\u4e0a\u306e\u66b4\u9732\u306f\u3001\u8abf\u67fb\u54e1\u306e\u8a8d\u77e5\u304b\u308924\u6642\u9593\u4ee5\u5185\u306b\u30d5\u30a1\u30a4\u30b6\u30fc\u30bb\u30fc\u30d5\u30c6\u30a3\u306b\u5831\u544a\u306e\u3053\u3068\u3002<\/span><\/span><\/span><\/div>\n
<\/div>\n
8.3.5.1. \u598a\u5a20\u4e2d\u306e\u66dd\u9732\uff08EDP\uff09<\/span><\/strong><\/div>\n
\u3000EDP\u306f\u4ee5\u4e0b\u306e\u69d8\u306a\u6642\u306b\u8d77\u304d\u308b\u3002<\/span>An EDP occurs if:<\/span><\/span>
\n\u2022 A female participant is found to be pregnant while receiving or after discontinuing study intervention. \u2028<\/span>
\n\u5973\u6027\u306e\u88ab\u9a13\u8005\u304c\u30ef\u30af\u30c1\u30f3\u306e\u6cbb\u9a13\u4e2d\u3001\u3042\u308b\u3044\u306f\u6cbb\u9a13\u4e2d\u65ad\u5f8c\u306b\u598a\u5a20\u306b\u6c17\u3065\u3044\u305f\u6642\u3002<\/span><\/div>\n
\u2022 A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception. \u2028<\/span>
\n\u7537\u6027\u306e\u88ab\u9a13\u8005\u304c\u30ef\u30af\u30c1\u30f3\u306e\u6cbb\u9a13\u4e2d\u3001\u3042\u308b\u3044\u306f\u6cbb\u9a13\u3092\u4e2d\u65ad\u3057\u305f\u5f8c\u306b\u5973\u6027\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u598a\u5a20\u524d\u5f8c\u306b\u66b4\u9732\u3055\u305b\u305f\u6642\u3002<\/span><\/span><\/div>\n
\u2022 A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy: \u2028<\/span><\/span>
\n\u5973\u6027\u304c\u66b4\u9732\u4e2d\u306b\u598a\u5a20\u307e\u305f\u306f\u6cbb\u9a13\u4e2d\u306e\u74b0\u5883\u304b\u3089\u306e\u66dd\u9732<\/u>\u3067\u598a\u5a20\u3057\u305f\u5834\u5408\u3002<\/span><\/div>\n
\u74b0\u5883\u304b\u3089\u306e\u66dd\u9732<\/u>(environmental exposure)\u306b\u306f\u4ee5\u4e0b\u304c\u3042\u308b\u3002<\/span><\/div>\n
\u2022 A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention\u00a0by inhalation or <\/u><\/span>skin contact<\/u>.<\/span>
\n\u5973\u6027\u306e\u5bb6\u65cf\u3001\u307e\u305f\u306f\u533b\u7642\u5f93\u4e8b\u8005\u304c\u3001<\/span>\u88ab\u9a13\u8005\uff08\u30ef\u30af\u30c1\u30f3\u3092\u6253\u3063\u305f\u4eba\uff09\u304b\u3089\u5438\u5165\u3001\u3042\u308b\u3044\u306f\u76ae\u819a\u63a5\u89e6\u306b\u3088\u3063\u3066\u66dd\u9732\u3057\u305f\u3068\u304d\u3002<\/span><\/span><\/div>\n
\u2022<\/span><\/span>A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception.<\/span><\/span><\/div>\n
\u7537\u6027\u306e\u5bb6\u65cf\u3001\u307e\u305f\u306f\u533b\u7642\u5f93\u4e8b\u8005\u304c\u3001\u88ab\u9a13\u8005\u304b\u3089\u5438\u5165\u3001\u3042\u308b\u3044\u306f\u76ae\u819a\u63a5\u89e6\u306b\u3088\u3063\u3066\u66dd\u9732\u3057\u305f\u5f8c\u306b\u3001\u5973\u6027\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u598a\u5a20\u524d\u5f8c\u306b\u66b4\u9732\u3055\u305b\u305f\u3055\u305b\u305f\u3068\u304d\u3002<\/span><\/div>\n
\n

The investigator must report EDP to Pfizer Safety within 24 hours of the investigator\u2019s <\/span>awareness, irrespective of whether an SAE has occurred. The initial information submitted <\/span>should include the anticipated date of delivery (see below for information related to <\/span>termination of pregnancy).<\/span><\/p>\n

\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306f\u300124\u6642\u9593\u4ee5\u5185\u306bEDP\u3092\u30d5\u30a1\u30a4\u30b6\u30fc\u30bb\u30fc\u30d5\u30c6\u30a3\u306b\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 \u6df1\u523b\u306a\u526f\u53cd\u5fdcSAE\u304c\u767a\u751f\u3057\u305f\u304b\u3069\u3046\u304b\u306b\u95a2\u4fc2\u306a\u304f\u3001\u63d0\u51fa\u3055\u308c\u305f\u521d\u671f\u60c5\u5831\u306b\u306f\u51e1\u305d\u306e\u767a\u75c7\u65e5\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff08\u6d41\u7523\u306b\u95a2\u9023\u3059\u308b\u60c5\u5831\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\uff09<\/span><\/span><\/p>\n

\u2022 If EDP occurs in a participant or a participant\u2019s partner, the investigator must report <\/span>this information to Pfizer Safety on the Vaccine SAE Report Form and an EDP <\/span>Supplemental Form, regardless of whether an SAE has occurred. Details of the <\/span>pregnancy will be collected after the start of study intervention and until 6 months<\/span>
\nafter the last dose of study intervention.<\/span>\u53c2\u52a0\u8005\u307e\u305f\u306f\u53c2\u52a0\u8005\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u3067EDP\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001SAE\u304c\u767a\u751f\u3057\u305f\u304b\u3069\u3046\u304b\u306b\u95a2\u4fc2\u306a\u304f\u3001\u8abf\u67fb\u54e1\u306f\u3053\u306e\u60c5\u5831\u3092\u30ef\u30af\u30c1\u30f3SAE\u30ec\u30dd\u30fc\u30c8\u30d5\u30a9\u30fc\u30e0\u304a\u3088\u3073EDP\u88dc\u8db3\u30d5\u30a9\u30fc\u30e0\u3067\u30d5\u30a1\u30a4\u30b6\u30fc\u30bb\u30fc\u30d5\u30c6\u30a3\u306b\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u598a\u5a20\u306e\u8a73\u7d30\u306f\u3001\u6cbb\u9a13<\/span><\/span>\u306e\u958b\u59cb\u5f8c\u30016\u30f6\u6708\u307e\u3067\u53ce\u96c6\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n

\u2022 If EDP occurs in the setting of environmental exposure, the investigator must report <\/span>information to Pfizer Safety using the Vaccine SAE Report Form and EDP <\/span>Supplemental Form. Since the exposure information does not pertain to the <\/span>participant enrolled in the study, the information is not recorded on a CRF; however,<\/span>
\na copy of the completed Vaccine SAE Report Form is maintained in the investigator <\/span>site file.<\/span>\u74b0\u5883\u66dd\u9732\u306e\u8a2d\u5b9a\u3067EDP\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u8abf\u67fb\u54e1\u306f\u30ef\u30af\u30c1\u30f3SAE\u30ec\u30dd\u30fc\u30c8\u30d5\u30a9\u30fc\u30e0\u3068EDP\u88dc\u8db3\u30d5\u30a9\u30fc\u30e0\u3092\u4f7f\u7528\u3057\u3066\u30d5\u30a1\u30a4\u30b6\u30fc\u30bb\u30fc\u30d5\u30c6\u30a3\u306b\u60c5\u5831\u3092\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3070\u304f\u9732\u60c5\u5831\u306f\u7814\u7a76\u306b\u767b\u9332\u3055\u308c\u305f\u53c2\u52a0\u8005\u306b\u95a2\u4fc2\u3057\u306a\u3044\u305f\u3081\u3001\u60c5\u5831\u306fCRF\u306b\u8a18\u9332\u3055\u308c\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u306a\u304c\u3089\u3001 \u8a18\u5165\u6e08\u307f\u306e\u30ef\u30af\u30c1\u30f3SAE\u30ec\u30dd\u30fc\u30c8\u30d5\u30a9\u30fc\u30e0\u306e\u30b3\u30d4\u30fc\u306f\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u30b5\u30a4\u30c8\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u6301\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n

8.3.5.2. Exposure During Breastfeeding<\/span><\/strong><\/p>\n<\/div>\n

\u3068\u3042\u308a\u3001\u30ef\u30af\u30c1\u30f3\u3092\u63a5\u7a2e\u3057\u305f\u5f8c\u306b\u6bcd\u4e73\u80b2\u5150\u4e2d\u3060\u3063\u305f\u4eba\u306f\u5831\u544a\u3059\u308b\u3053\u3068\u3002\uff08\u5185\u5bb9\u7701\u7565\uff09<\/span><\/div>\n
\n
<\/div>\n
8.3.5.3. Occupational Exposure<\/span><\/strong><\/div>\n
\u8077\u696d\u4e0a\u306e\u66dd\u9732<\/span><\/div>\n
“An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant\u2019s care.”<\/span><\/div>\n
\u8077\u696d\u4e0a\u306e\u66dd\u9732\u306f<\/span>\u30ef\u30af\u30c1\u30f3\u3092\u6253\u3063\u305f\u4eba\u306b\u4e88\u671f\u305b\u305a\u76f4\u63a5\u63a5\u89e6\u3057\u305f\u6642\u306b\u8d77\u3053\u308b<\/u>\u3002<\/span>\u305d\u306e\u7d50\u679c\u3001\u5fc5\u305a\u3057\u3082AE\u304c\u8d77\u304d\u308b\u3053\u3068\u306f\u306a\u3044\u304c\u3002<\/span>\u305d\u306e\u3088\u3046\u306a\u4eba\u306b\u306f\u3001\u533b\u7642\u95a2\u4fc2\u8005\u3001\u5bb6\u65cf\u3001\u305d\u3057\u3066\u88ab\u9a13\u8005\u306e\u4e16\u8a71\u3092\u3059\u308b\u5f79\u5272\u3092\u62c5\u3063\u305f\u4eba<\/u>\u304c\u542b\u307e\u308c\u308b\u3002<\/span><\/div>\n
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the investigator\u2019s awareness, regardless of whether there is an associated SAE.<\/span><\/div>\n
\u8abf\u67fb\u54e1\u306f\u300c\u8077\u696d\u4e0a\u306e\u66dd\u9732\u300d\u306b\u6c17\u3065\u3044\u305f\u5834\u5408\u3001<\/span>SAE\uff08\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\uff09\u306e\u6709\u7121\u306b\u95a2\u308f\u3089\u305a<\/span>24\u6642\u9593\u4ee5\u5185\u306b\u30d5\u30a1\u30a4\u30b6\u30fc\u5b89\u5168\u6027\u90e8\u9580\u306b\u5831\u544a\u3057\u306a\u304f\u3066\u306f\u306a\u3089\u306a\u3044\u3002<\/span><\/div>\n
\n
\n<\/div>\n<\/div>\n
\u4ee5\u4e0a\u7d39\u4ecb\u3057\u305f\u5185\u5bb9\u304b\u3089\u3044\u3048\u308b\u3053\u3068<\/span><\/strong><\/div>\n
<\/div>\n
\u30ef\u30af\u30c1\u30f3\u3092\u6253\u3063\u305f\u4eba\u306e\u547c\u6c17\u3092\u5438\u5165\u3057\u305f\u308a\u3001<\/span>\u76ae\u819a\u3092\u63a5\u89e6\u3055\u305b\u305f\u5834\u5408\u3082\u5831\u544a\u3068\u3044\u3046\u306e\u306f<\/span>\u4f55\u306e\u53ef\u80fd\u6027\u3092\u5ff5\u982d\u306b\u8a2d\u8a08\u3055\u308c\u305f\u6cbb\u9a13\u306a\u306e\u304b\u3002\u5c11\u306a\u304f\u3068\u3082\u3001\u5192\u982d\u306b\u8ff0\u3079\u305f\u300c\u30ef\u30af\u30c1\u30f3\u63a5\u7a2e\u8005\u304c\u5468\u56f2\u306b\u75c5\u6c17\u3092\u307e\u304d\u6563\u3089\u3059\u300d\u3068\u3044\u3063\u305f\u3053\u3068\u306e\u53ef\u80fd\u6027\u306e\u5426\u5b9a\u306b\u306f\u306a\u3089\u306a\u3044\u3060\u308d\u3046\u3002\u3042\u308b\u3044\u306f\u3001\u6cbb\u9a13\u5bfe\u8c61\u3068\u3057\u3066\u598a\u5a66\u30fb\u598a\u5a20\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u306f\u9664\u5916\u3055\u308c\u3066\u3044\u308b\u3068\u8a00\u308f\u308c\u3066\u3044\u308b<\/a><\/span>\u304c\u3001\u4f55\u3092\u610f\u56f3\u3057\u3066\u3044\u308b\u306e\u304b\u3002<\/span><\/span><\/span><\/div>\n
\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u9593\u3068\u306e\u6bd4\u8f03\u306b\u904e\u304e\u306a\u3044\uff19\uff15\uff05\u306e\u6709\u52b9\u6027\u3068\u3044\u3046\u6570\u5b57\u304c\u5148\u884c\u3057\u3066\u3001\u5168\u4f53\u306e\u7f79\u60a3\u7387\u304c\u7c73\u56fd\u3067\u306f\uff11\uff05\u306b\u6e80\u305f\u306a\u3044\u3053\u3068\u306b\u52a0\u3048\u3001\u65e5\u672c\u3067\u306f\u3055\u3089\u306b\u305d\u308c\u306e\uff11\uff10\uff10\u5206\u306e\uff11\u7a0b\u5ea6\u306e\u3082\u306e\u306b\u4f55\u6545\u3053\u308c\u307b\u3069\u307e\u3067\u306b\u60d1\u308f\u3055\u308c\u308b\u306e\u304b\u3002\u611f\u67d3\u75c7\uff12\u985e\u6307\u5b9a<\/a><\/span>\u3092\u5916\u3055\u306a\u3044\u9650\u308a\u3001\u3053\u306e\u6df7\u6c8c\u306e\u72b6\u6cc1\u306f\u5909\u308f\u3089\u306a\u3044\u3002\u305d\u3057\u3066\u3001\u6cbb\u7642\u3068\u3044\u3046\u533b\u7642\u672c\u6765\u306e\u8cac\u4efb\u3092\u5fd8\u308c\u3055\u305b\u3089\u308c\u305f<\/a><\/span>\u30ef\u30af\u30c1\u30f3\u5916\u4ea4\u306b\u4e57\u305b\u3089\u308c\u6557\u5317\u3059\u308b\u65e5\u672c\u5916\u4ea4\u306e\u59ff\u304c\u3042\u308b\u3002<\/span><\/span><\/span><\/div>\n
<\/div>\n","protected":false},"excerpt":{"rendered":"

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