药物临床试验 受试者损害处理•广东共识(2020年版)

2020-03-05 广东省药学会 广东省药学会

各医疗单位:

中文标题:

药物临床试验 受试者损害处理•广东共识(2020年版)

发布机构:

广东省药学会

发布日期:

2020-03-05

简要介绍:

各医疗单位:

为规范药物临床试验受试者损害处理行为,切实保护受试者安全和权益,促进新药临床试验良好发展,本会药物临床试验专业委员会编写了《药物临床试验 受试者损害处理•广东共识(2020年版)》,现予以发布,供各医疗单位参考。各单位在执行过程中遇到与本共识相关的任何问题,请及时向本会反映。

联系地址:广州市东风东路753号东塔7楼 广东省药学会  510080

联系电话:(020)37886326,37886321

传真:37886330

电子邮箱:gdsyxh45@126.com

网址:http://www.sinopharmacy.com.cn

 

相关资料下载:
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#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2021-07-25 孤云独闲两不厌

    如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2020-11-29 146636e7m23暂无昵称

    学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2020-08-06 飞翔的乌龟

    学习了,很棒的资料

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2020-08-04 月瘦如眉

    学习

    0