{"id":180413,"date":"2020-11-02T01:53:40","date_gmt":"2020-11-02T08:53:40","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/patient-safety-narratives\/"},"modified":"2022-06-15T17:45:47","modified_gmt":"2022-06-16T00:45:47","slug":"%e6%82%a3%e8%80%85%e5%ae%89%e5%85%a8%e5%8f%99%e8%bf%b0%e7%bf%bb%e8%af%91","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%82%a3%e8%80%85%e5%ae%89%e5%85%a8%e5%8f%99%e8%bf%b0%e7%bf%bb%e8%af%91\/","title":{"rendered":"\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u7ffb\u8bd1"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|0px|0px”][et_pb_fullwidth_header button_one_text=”\u7acb\u5373\u8054\u7cfb\u6211\u4eec” button_one_url=”https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%81%94%e7%b3%bb\/” background_overlay_color=”rgba(0,0,0,0.28)” content_max_width=”60%” content_max_width_tablet=”” content_max_width_phone=”” content_max_width_last_edited=”on|desktop” module_class=”hide-h1″ _builder_version=”4.5.3″ content_font=”||||||||” content_font_size=”22px” content_line_height=”1.6em” subhead_font=”||||||||” background_color=”rgba(255,255,255,0)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/11\/patient-safety-narratives1.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”80px||100px|” custom_padding_tablet=”” custom_padding_phone=”50px||50px|” custom_padding_last_edited=”on|desktop” hover_enabled=”0″ content_font_size_tablet=”” content_font_size_phone=”17px” content_font_size_last_edited=”on|desktop” button_one_text_size__hover_enabled=”off” button_one_text_size__hover=”null” button_two_text_size__hover_enabled=”off” button_two_text_size__hover=”null” button_one_text_color__hover_enabled=”off” button_one_text_color__hover=”null” button_two_text_color__hover_enabled=”off” button_two_text_color__hover=”null” button_one_border_width__hover_enabled=”off” button_one_border_width__hover=”null” button_two_border_width__hover_enabled=”off” button_two_border_width__hover=”null” button_one_border_color__hover_enabled=”off” button_one_border_color__hover=”null” button_two_border_color__hover_enabled=”off” button_two_border_color__hover=”null” button_one_border_radius__hover_enabled=”off” button_one_border_radius__hover=”null” button_two_border_radius__hover_enabled=”off” button_two_border_radius__hover=”null” button_one_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover=”null” button_two_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover=”null” button_one_bg_color__hover_enabled=”off” button_one_bg_color__hover=”null” button_two_bg_color__hover_enabled=”off” button_two_bg_color__hover=”null”]<\/p>\n

\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u7ffb\u8bd1<\/h1>\n

\u63d0\u4f9b250\u591a\u79cd\u8bed\u8a00\u7684\u9ad8\u8d28\u91cf\u7684\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u7ffb\u8bd1\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n

[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”23px|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ custom_padding=”0|0px|0|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][divienhancer_breadcrumb _builder_version=”3.20.2″][\/divienhancer_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ parallax=”on”][et_pb_row _builder_version=”3.25″ custom_padding=”0px||0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” custom_padding=”30px|||” custom_padding_tablet=”” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”on|desktop” hover_enabled=”0″]\u5728\u4e34\u5e8a\u7814\u7a76\u671f\u95f4\uff0c\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u662f\u4e0e\u4e34\u5e8a\u5b89\u5168\u62a5\u544a\u548c\u652f\u6301\u836f\u7269\u8b66\u6212\u6d3b\u52a8\u76f8\u5173\u7684\u5fc5\u8981\u6587\u4ef6\u4e4b\u4e00\uff0c\u8fd9\u4f7f\u5f97\u60a3\u8005\u53d9\u8ff0\u7684\u7ffb\u8bd1\u5bf9\u4e8e\u786e\u4fdd\u4e0e\u8bd5\u9a8c\u836f\u7269\u548c\u7814\u7a76\u4ea7\u54c1\u6709\u5173\u5185\u5bb9\u7684\u4e00\u81f4\u6027\u3001\u51c6\u786e\u6027\u548c\u900f\u660e\u6027\u81f3\u5173\u91cd\u8981\u3002\u6839\u636e\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6280\u672f\u8981\u6c42\u534f\u8c03\u59d4\u5458\u4f1a\uff08ICH\uff09E3\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\uff08CSR\uff09\u6307\u5357\u7684\u89c4\u5b9a\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6240\u6709\u9636\u6bb5\u90fd\u9700\u8981\u5408\u89c4\u7684\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u3002\u8fd9\u4e9b\u53d9\u8ff0\u5305\u62ecSAE\uff08\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff09\u3001\u6b7b\u4ea1\u548cAESI\uff08\u7279\u522b\u5173\u6ce8\u7684\u4e0d\u826f\u4e8b\u4ef6\uff09\uff0c\u6216\u90a3\u4e9b\u5f15\u53d1\u7814\u7a76\u4e2d\u6b62\u7684\u53d9\u8ff0\uff0c\u5b83\u4eec\u603b\u7ed3\u8bb0\u5f55\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u7684\u91cd\u8981\u4e8b\u4ef6\u3002<\/p>\n

\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u662f\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\uff08CSR\uff09\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u6709\u52a9\u4e8e\u8bc4\u4f30\u7814\u7a76\u4ea7\u54c1\u7684\u5b89\u5168\u72b6\u51b5\u3002\u6b64\u5916\uff0c\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u5fc5\u987b\u9075\u5faa\u7279\u5b9a\u7684\u98ce\u683c\u6307\u5357\u548c\u683c\u5f0f\uff0c\u4ee5\u4fbf\u901a\u8fc7\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u6570\u636e\u5b89\u5168\u76d1\u6d4b\u59d4\u5458\u4f1a\uff08DSMB\uff09\u6216\u5176\u4ed6\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u6838\u3002<\/p>\n

\u4e3a\u4e86\u5e2e\u52a9\u8bd5\u9a8c\u7533\u529e\u8005\u548c\u5408\u540c\u7814\u7a76\u7ec4\u7ec7\uff08CRO\uff09\u9075\u5b88\u56fd\u9645\u6cd5\u89c4\u5e76\u4ee5\u4e0d\u540c\u8bed\u8a00\u64b0\u5199\u5b89\u5168\u62a5\u544a\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u7684\u533b\u5b66\u5199\u4f5c\u4e13\u5bb6\u4ee5\u53ca\u4e3b\u9898\u4e13\u5bb6\u5171\u540c\u5408\u4f5c\uff0c\u53ef\u63d0\u4f9b250\u591a\u79cd\u8bed\u8a00<\/u><\/a>\u7248\u672c\u7684\u5177\u6709\u6210\u672c\u6548\u76ca\u548c\u51c6\u786e\u7684\u60a3\u8005\u53d9\u8ff0\u7ffb\u8bd1\u3002
\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#f9f9f9″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/11\/patient-safety-narratives3.jpg” parallax=”on”][et_pb_row make_equal=”on” _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” hover_enabled=”0″ custom_padding=”||0px||false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_2_font=”||||||||” header_3_font=”||||||||” header_3_text_color=”#ffffff” hover_enabled=”0″]<\/p>\n

\u533b\u5b66\u5199\u4f5c\u7ffb\u8bd1<\/h2>\n

\u4e3a\u4e86\u4f7f\u60a3\u8005\u5b89\u5168\u53d9\u8ff0\u7b26\u5408ICH E3\u6807\u51c6\uff0c\u53d9\u8ff0\u5e94\u6d89\u53ca\u5982\u4e0b\u65b9\u9762\uff1a\u4e8b\u4ef6\u7684\u6027\u8d28\u3001\u5f3a\u5ea6\u548c\u7ed3\u679c\uff0c\u56f4\u7ed5\u6240\u4f7f\u7528\u7684\u7814\u7a76\u836f\u7269\u7684\u7ec6\u8282\uff0c\u662f\u5426\u505c\u836f\uff0c\u5e76\u5e94\u53d9\u8ff0\u4e8b\u4ef6\u7684\u6f14\u53d8\u8fc7\u7a0b\u3001\u4f34\u968f\u7528\u836f\u3001\u75c5\u53f2\u3001\u6b7b\u4ea1\u65f6\u7684\u5c38\u68c0\u7ed3\u679c\uff0c\u5e76\u5e94\u63d0\u4f9b\u56e0\u679c\u5173\u7cfb\u8bc4\u4f30\u3002<\/p>\n

\u9664\u4e86\u5bf9\u6cbb\u7597\u9886\u57df\u4ee5\u53ca\u76f8\u5173\u6cd5\u89c4\u6709\u5145\u5206\u7684\u4e86\u89e3\u5916\uff0c\u53d9\u8ff0\u6027\u5199\u4f5c\u548c\u533b\u5b66\u5199\u4f5c\u670d\u52a1\u8fd8\u8981\u6c42\u51fa\u8272\u7684\u9879\u76ee\u7ba1\u7406\u6280\u80fd\uff0c\u56e0\u4e3a\u5b83\u9700\u8981\u4e0e\u591a\u4e2a\u5229\u76ca\u76f8\u5173\u8005\u8fdb\u884c\u534f\u8c03\uff0c\u4ee5\u63a8\u52a8\u6570\u636e\u6765\u6e90\u3001\u683c\u5f0f\u3001\u6a21\u677f\u3001\u622a\u6b62\u65e5\u671f\u3001\u53d9\u8ff0\u64b0\u5199\u65f6\u673a\u7b49\u65b9\u9762\u7684\u4e00\u81f4\u6027\u3002\u6211\u4eec\u5728\u60a3\u8005\u53d9\u8ff0\u7684\u672c\u5730\u5316\u65b9\u9762\u6709\u6210\u719f\u7684\u7ecf\u9a8c\uff0c\u53ef\u4ee5\u4e3a\u6240\u6709\u7c7b\u578b\u7684\u533b\u7597\u5199\u4f5c\u63d0\u4f9b\u7ffb\u8bd1\uff0c\u5305\u62ec\uff1a
\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_color=”#ffffff” header_3_font=”||||||||” header_3_text_color=”#ffffff” hover_enabled=”0″]<\/p>\n