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国家卫生健康委发布《医疗卫生机构开展研究者发起的临床研究管理办法（试行）》

2021-09-10 NCCGCP1962 NCCGCP1962

临床研究临床研究设计医疗卫生机构
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2021年9月9日上午，

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2021年9月9日上午，国家卫生健康委在北京召开医疗卫生机构临床研究规范管理试点工作启动会，正式发布《医疗卫生机构开展研究者发起的临床研究管理办法（试行）》（以下简称《管理办法》），定于2021年10月1日在北京市、上海市、广东省和海南省先行试点实施。国家卫生健康委副主任 曾益新，科教司监察专员 刘登峰、副司长 顾金辉，医政医管局副局长 李大川，科教司二级巡视员 王锦倩、重大专项处副处长 柴慧婷等出席会议，就开展试点工作给出重要指示。中国医学科学院肿瘤医院院长助理 李宁、科研处副处长 杜君参加此次会议。
管理促进发展《管理办法》中规定，医疗卫生机构开展临床研究，均应通过科学性审查和伦理审查。在研究过程中，要充分尊重研究对象的知情权和自主选择权。《管理办法》要求医疗卫生机构制定切实有效的临床研究管理实施细则，健全临床研究内部管理和支撑服务保障，加强对临床研究的全过程监管，根据临床研究的研究类型及潜在风险进行分类管理。并在医疗卫生机构健全内部管理制度的基础上，建立省级技术和行政监督管理体系，强化对医疗卫生机构临床研究管理的监督检查，及时纠正问题，指导临床研究规范开展。
曾益新主任强调，目前对研究者发起临床研究规范管理远远落后于现实需求，缺乏有效的监督管理体系。应当对于研究者发起研究给予和申办方发起的注册临床研究给予同样重视，有条件的医院，应考虑在同一部门下进行统一管理，建立专业的监督管理队伍。曾益新主任指出，管理是为了更好的促进发展，应当尊重专家，尊重机构，简化审批程序，注重研究内涵建设，建立临床研究人才发展培养体系。《管理办法》试点工作中的重点之一是强化对研究者的培训和服务支撑。要求医疗服务机构发挥好科学性审查、伦理审查、立（结）项环节的教育和服务支撑功能，帮助引导研究者提高研究质量。鼓励试点省份和医疗服务机构积极探索设立临床研究专项资金，建立临床研究管理服务平台，为临床研究提供资金、方法学指导、随访管理、数据存储分析等专业技术支撑，全方位助力研究者开展高质量临床研究。高质量管理体系保障研究者发起临床研究全程规范开展，高质量支撑体系为研究者发起研究提供资金、设备、技术保障及人才培养路径。
《管理办法》试点工作的开展，将为规范管理研究者发起临床研究积累宝贵的经验，推动我国研究者发起研究走上有序、高效、高质量发展的快速路。持续规范IIT管理中国医学科学院肿瘤医院GCP中心实行一体化管理体制以来，对研究者发起研究和申办方发起注册临床研究采用同质化管理手段，建立了完备的研究者发起临床研究管理制度。同时，GCP中心为部分高水平IIT研究，提供研究统计设计、试验药品管理、免费EDC系统等，下属的研究病房及临床研究门诊也同样为IIT研究提供患者收治和受试者招募、随访等服务，帮助研究者解决执行过程中的痛点问题，助力开展高质量临床研究。十三五期间，全院立项研究者发起临床研究891项，年均增长率达到了46%。
《医疗卫生机构开展研究者发起的临床研究管理办法（试行）》颁布后，我中心将根据《管理办法》要求，结合中心现有工作制度，继续修订完善我院研究者发起临床研究管理实施细则，在国家及北京市卫健委的指导下，切实做好研究者发起研究的管理和服务工作。

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    2022-04-24 stfoxst

    #研究者#

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    2022-01-16 zhangmingxiang

    #卫生机构#

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content=<a href='/topic/show?id=4cd534866c9' target=_blank style='color:#2F92EE;'>#医疗卫生#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=34866, encryptionId=4cd534866c9, topicName=医疗卫生)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ee212178304, createdName=wangtianj2011@, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568178, encodeId=ded215681e817, content=<a href='/topic/show?id=85a54086193' target=_blank style='color:#2F92EE;'>#国家卫生健康委#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40861, encryptionId=85a54086193, topicName=国家卫生健康委)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2b3515322450, createdName=xiaoshitou, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=)]
    2022-04-03 yyanpro@34cn.c

    #健康委#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=2032780, encodeId=83fc2032e8009, content=<a href='/topic/show?id=ff85e343730' target=_blank style='color:#2F92EE;'>#研究者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73437, encryptionId=ff85e343730, topicName=研究者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Sun Apr 24 21:35:32 CST 2022, time=2022-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1989734, encodeId=a1e71989e34a9, content=<a href='/topic/show?id=69313664156' target=_blank style='color:#2F92EE;'>#卫生机构#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36641, encryptionId=69313664156, topicName=卫生机构)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c6fc262, 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channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=34876, encryptionId=6243348e67c, topicName=医疗卫生机构)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=22138785246, createdName=3631176, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1493060, encodeId=230514930606a, content=<a href='/topic/show?id=d98f3660e57' target=_blank style='color:#2F92EE;'>#卫生健康#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36607, encryptionId=d98f3660e57, topicName=卫生健康)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=60488981755, createdName=wangyang7961, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530983, encodeId=f8921530983bd, content=<a href='/topic/show?id=4cd534866c9' target=_blank style='color:#2F92EE;'>#医疗卫生#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=34866, encryptionId=4cd534866c9, topicName=医疗卫生)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ee212178304, createdName=wangtianj2011@, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568178, encodeId=ded215681e817, content=<a href='/topic/show?id=85a54086193' target=_blank style='color:#2F92EE;'>#国家卫生健康委#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40861, encryptionId=85a54086193, topicName=国家卫生健康委)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2b3515322450, createdName=xiaoshitou, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=)]
    2022-01-13 zengjiayao

    #管理办法#

    0

  5. 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channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=34876, encryptionId=6243348e67c, topicName=医疗卫生机构)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=22138785246, createdName=3631176, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1493060, encodeId=230514930606a, content=<a href='/topic/show?id=d98f3660e57' target=_blank style='color:#2F92EE;'>#卫生健康#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36607, encryptionId=d98f3660e57, topicName=卫生健康)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=60488981755, createdName=wangyang7961, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530983, encodeId=f8921530983bd, content=<a href='/topic/show?id=4cd534866c9' target=_blank style='color:#2F92EE;'>#医疗卫生#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=34866, encryptionId=4cd534866c9, topicName=医疗卫生)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ee212178304, createdName=wangtianj2011@, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568178, encodeId=ded215681e817, content=<a href='/topic/show?id=85a54086193' target=_blank style='color:#2F92EE;'>#国家卫生健康委#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40861, encryptionId=85a54086193, topicName=国家卫生健康委)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2b3515322450, createdName=xiaoshitou, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=)]
    2021-09-12 tidiq

    #卫生健康委#

    0

  6. 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content=<a href='/topic/show?id=4cd534866c9' target=_blank style='color:#2F92EE;'>#医疗卫生#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=34866, encryptionId=4cd534866c9, topicName=医疗卫生)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ee212178304, createdName=wangtianj2011@, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568178, encodeId=ded215681e817, content=<a href='/topic/show?id=85a54086193' target=_blank style='color:#2F92EE;'>#国家卫生健康委#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40861, encryptionId=85a54086193, topicName=国家卫生健康委)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2b3515322450, createdName=xiaoshitou, createdTime=Sun Sep 12 02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=)]
    2021-09-12 3631176

    #医疗卫生机构#

    0

  7. 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02:35:32 CST 2021, time=2021-09-12, status=1, ipAttribution=)]
    2021-09-12 wangyang7961

    #卫生健康#

    0

  8. 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    2021-09-12 wangtianj2011@

    #医疗卫生#

    0

  9. 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    2021-09-12 xiaoshitou

    #国家卫生健康委#

    0

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