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中华医学科研管理杂志
中华医学科研管理杂志编辑
中华医学科研管理杂志

中华医学科研管理杂志编辑

罗长坤

双月刊

1006-1924

kgzz@bjmu.edu.cn

010-82802217

100191

北京市海淀区学院路38号北京大学医学部

中华医学科研管理杂志/Journal Chinese Journal of Medical Science Research ManagementCSTPCD
查看更多>>1988年创刊，中华医学会主办。本刊是专门报道医学科研管理学的学术期刊。以宣传党和国家科技工作的方针政策，反映我国医学科研管理学科的研究成果及进展为主要目的；以全国卫生行政、高等医学院校、医院、卫生防疫机构和科研机构的领导、科研管理干部及参与医学科研管理活动的其他科学专家、学者为主要读者对象。设有理论研讨、方法研讨、科研课题与项目、科技成果管理，学科建设与人才管理，临床与预防医学科研管理等栏目。
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    卫生健康科技管理的思路与着力点探讨

    顾金辉
    1-6页
    查看更多>>摘要：目的 在科技体制改革和科研范式转变的背景下，探讨提出卫生健康科技管理的思路和着力点。 方法 综合理论研究、政策研究，采用对比分析、归纳总结等方法，探讨行业科技管理的思路和政策着力点。 结果/结论 总体思路是推动卫生健康科技管理从狭义"科研管理"拓展为广义"科技管理"，通过强化行业科技管理，推动宏观科技政策扎实落地，面向人民生命健康，统筹科技资源、力量，推进领域科技攻关，强化科技创新对卫生健康的支撑作用。主要着力点包括：(1)立足需求、组织研发任务，(2)规范管理、完善政策体系，(3)统筹资源、协同基地平台，(4)依托实践、建设人才队伍，(5)强化监管、优化创新生态等5个方面。 Objective In the context of the S&T system reforming and research paradigm transforming, the overall thought and the key tasks were proposed. Methods Combining the theorical & policy analysis, the overall thought and the key points in sectoral S&T management were proposed by the method of comparative and inductive analysis. Results/Conclusions The overall thought is to expend the narrow sense of "research management" to the broad sense of "S&T management", to promote the macro technology policy to be implemented, and advance the technology breakthroughs by facing the people’s life and health and coordinating the technology resources and forces, so as to enhance the supporting role of S&T innovation for health. The key task points are as follows, i. e., organizing R&D tasks by focusing on the health demand (1 st), standardizing the management by improving policy system (2nd), coordinating the resources by integrating the diverse platforms (3rd), constructing the talents staff by the research practicing (4th), optimizing the innovation ecology by strengthening supervision (5th).

    行业科技管理卫生健康科技科技体制改革

      原文链接:
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    人类遗传资源数据的管理现状和思考

    李娜鲁杨胡婷旷苗...
    7-13页
    查看更多>>摘要：目的 研究人类遗传资源数据的管理现状，为进一步推进和规范我国人类遗传资源数据的管理提供参考。 方法 本文通过文献研读、专家咨询和政策研究等，从相关政策、管理架构、数据平台和样本数据库管理三个层次，分析人类遗传资源数据的管理现状。 结果 各国对人类遗传资源越来越重视，我国人类遗传资源管理体系建设也在不断推进和完善。数据时代下，人类遗传资源管理面临新的问题和挑战，需要进一步加强相关数据的研究和管理。 结论 当前，我国人类遗传资源数据的管理还有待加强。一方面要推进人类遗传资源数据具体制度的落地实施与协同管理，另一方面要加强人类遗传资源数据的有效保护和共享利用。 Objective To analysis the laws and regulations related to human genetic resources, this study analyzed the current management status and trends at home and abroad, explored the related issues of human genetic resources data management, and provided reference for further promoting and standardizing the management of human genetic resources data in my country. Methods This article analyzed the current management status of human genetic resources data from three levels: relevant policies, management frameworks, data platforms and sample databases through literature review and expert consultation and policy research. Results Countries paid more and more attention to human genetic resources, and the construction of my country′s human genetic resources management system is constantly advancing and improving. In the data era, the management of human genetic resources was facing new problems and challenges, requiring further strengthening the research and management of relevant data. Conclusions At present, the management of human genetic resource data in my country needs to be strengthened. On the one hand, it is necessary to promote the implementation and coordinated management of specific systems on human genetic resources data. On the other hand, it is necessary to strengthen the effective protection and sharing of human genetic resource data.

    人类遗传资源数据管理现状

      原文链接:
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    口腔医学领域人类遗传资源管理存在问题及对策探讨

    张琳单艳华徐明明刘妍...
    14-17页
    查看更多>>摘要：目的 对口腔医学领域人类遗传资源管理存在的问题进行分析，并探讨相应对策。 方法 通过对科技部人类遗传资源事项公示信息中口腔医学相关项目的整理分析，结合文献和科研管理负责人访谈，提炼总结口腔医疗机构人类遗传资源管理中存在的问题，并提出管理对策。 结果 口腔医学领域人类遗传资源利用活动获批项目61项，呈逐年增加趋势。其中口腔专科医疗机构为组长单位获批项目43项。口腔医疗机构人类遗传资源管理存在资源开发利用不足、生物样本库亟待发展和资源共享机制待完善等问题。访谈结果显示，人类遗传资源管理有待完善，管理部门和专业管理人员的制度建设和培训等方面有待加强。 结论 口腔医学院校和医疗机构应全面统筹机构人类遗传资源管理，建立健全管理体系，加强生物样本库建设，多途径拓展共享资源，充分利用人类遗传资源开展研究，促进口腔医学高质量发展。 Objective To analyze the problems in human genetic resource management in the field of stomatology and explore corresponding strategies. Methods By organizing and analyzing stomatological projects related to the disclosure of information on human genetic resources by the Ministry of Science and Technology, combined with literature analysis and interviews with research management leaders, the problems in human genetic resource management in stomatological institutions were summarized and management strategies were proposed. Results 61 projects were approved for the utilization of human genetic resources in the field of stomatology, showing an increasing trend year by year. Among them, 43 projects were approved by stomatological institutions as the team leader unit There are problems in the management of human genetic resources in stomatological institutions, such as insufficient resource development and utilization, urgent development of biological sample banks, and incomplete resource sharing mechanisms. The interview results show that the management of human genetic resources needs to be improved, and the management departments and professional management personnel, system construction, and training need to be strengthened. Conclusions Stomatological colleges and institutions should comprehensively coordinate the management of human genetic resources, establish a sound management system, strengthen the construction of biological sample banks, expand shared resources through multiple channels, fully utilize human genetic resources for research, and promote the high-quality development of stomatology.

    口腔医学人类遗传资源管理

      原文链接:
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    《人类遗传资源管理条例实施细则》对医疗机构国际合作中人类遗传资源管理带来的挑战及应对建议

    孔双蕾耿云飞魏锣沛白玲玲...
    18-21页
    查看更多>>摘要：目的 根据北京大学肿瘤医院国际合作项目人类遗传资源管理实践，结合人类遗传资源管理法律法规的发展方向，拟为医疗机构加强人类遗传资源管理提出参考建议。 方法 梳理2019年7月—2023年6月北京大学肿瘤医院在科技部政务平台中获得国际合作科学研究审批的项目，分析医院人类遗传资源管理现状，总结新的法规实施后对医疗机构人类遗传资源管理带来的挑战并提出应对建议。 结果 共获批1 276项人类遗传资源国际合作项目，其中首次申报345项，变更申报931项。涉及453项研究，其中药物或器械上市临床研究286项，占比63.13%，Ⅰ期药物临床试验100项，占上市研究的34.97%。上市研究平均每个项目变更3.14次，非上市研究平均每个项目变更1.56次。 结论 《人类遗传资源管理条例实施细则》(以下简称"《细则》")限缩涉及人类遗传资源的国际合作项目的管理范围，将管理权限下放到医疗机构；调整了国际合作临床试验备案的适用范围，可能导致部分行政审批项目转为备案；调整了人类遗传资源国际合作科学研究项目审批流程。建议医疗机构加强《细则》适用范围以外样本及知识产权的管理，加强国际合作科学研究的全过程管理，关注并及时传达人类遗传资源管理动态。 Objective According to the international cooperation project of Peking University Cancer Hospital on human genetic resource management practices, combined with the development direction of human genetic resource management laws and regulations, and propose reference suggestions for medical institutions to strengthen human genetic resource management. Methods Sort out the projects that Peking University Cancer Hospital obtained international cooperation approval on the government platform of the Ministry of Science and Technology from July 2019 to June 2023, analyze the current situation of human genetic resource management in the hospital, summarize the challenges brought by the implementation of new regulations on human genetic resource management in medical institutions, and propose corresponding suggestions. Results A total of 1276 international cooperation projects on human genetic resources have been approved, including 345 initial declarations and 931 change declarations. Involving 453 studies, including 286 clinical trials of drugs or devices on the market, accounting for 63.13%, and 100 clinical trials of Phase I drugs, accounting for 34.97% of the market studies. On average, there are 3.14 changes per project for listed research, and 1.56 changes per project for non listed research. Conclusions Regulations on the Management of Human Genetic Resources (short for Rules) limit the management scope of international cooperation projects involving human genetic resources and delegate management authority to medical institutions. Adjusting the scope of application for international cooperative clinical trial filing may result in some administrative approval projects being transferred to filing. The approval process for international cooperative scientific research projects on human genetic resources has been adjusted. Suggest medical institutions to strengthen the management of samples and intellectual property outside the scope of application of Rules.Strengthen the entire process management of international cooperation in scientific research. Pay attention to and timely communicate the dynamics of human genetic resource management.

    人类遗传资源管理条例细则医疗机构

      原文链接:
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    高校附属医院科技评价体系的建立与探索

    薛静张卓婧陈欣妤胡佩武...
    22-26页
    查看更多>>摘要：目的 立足国家高质量医院试点建设和国家医学中心建设需求构建科技评价体系。 方法 以国家"破五唯""立新标"的相关文件精神为指导，以"质量、贡献、效益、影响"为导向，以"高标准评价、量化性评价、代表作评价、第三方评价"为原则，以"临床研究与转化研究"为重点，逐步完善以实施分类评价为手段的学术评价指标体系。 结果 完成设置全面科学可量化的指标池，分别应用于科技激励、学科评估、职称晋升、人员考核、导师遴选和评优评先等医学创新评价相关工作。同时，建设基于绩效管理理论的高校附属医院医学创新评价与考核智能平台。 结论 通过湘雅科技评价体系建设与实践，进一步完善优化了医院科研学术评价工作，引导医院科研人员开展高质量创新和高效能转化，促进了医院高质量发展。 Objective To construct a scientific and technological evaluation system based on the needs of the pilot program for building a national high-quality hospital and establishing a national medical center. Methods Xiangya Hospital of Central South University gradually improved its academic evaluation system by following the guidelines outlined in national authorities′ documents regarding "abolishing the five only" and "setting new standards", adhering to the guiding principles of "quality, contribution, efficiency, and impact" and employing the principles of "high-standard evaluation, quantitative evaluation, representative work evaluation, and third-party evaluation" . Results The hospital established a comprehensive, scientific, and quantifiable indicator pool. These indicators were applied to various aspects of medical innovation evaluation, including awarding incentives, discipline assessment, professional promotion, personnel assessment, mentor selection for graduates, and excellence evaluation. Simultaneously, the hospital developed an intelligent platform for medical innovation evaluation and assessment in university-affiliated hospitals based on performance management theory. Conclusions Through the construction and practice of the Xiangya technology evaluation system, the hospital further improved and optimized its academic evaluation work, guiding researchers to high-quality innovation and efficient translational research, ultimately promoting the high-quality development of the hospital.

    科技评价体系公立医院体系建设

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    临床试验立项审查的问题分析及审查要点探索

    张滨梁雁
    27-33页
    查看更多>>摘要：目的 在我国新药审评审批制度持续改革的推动下，临床试验各项管理流程在持续改进和完善。本文旨在探索临床试验机构对临床试验立项的审查要点，为进一步优化立项审查标准提供建议。 方法 本文通过梳理临床试验立项管理的法规要求，结合医院情况，分析立项申请一次审核通过情况及立项审查中发现的问题，探索可能影响立项申请一次审核通过的因素及临床试验立项审查要素和标准。 结果 2020—2022年，医院共受理了514项以注册为目的的临床试验项目立项申请，一次审核通过的百分比为30.2%。是否作为组长单位和单中心临床试验是立项申请一次审核通过的影响因素(P<0.05)。在立项审查中，药物临床试验的问题位居前几位的分别是申办者资质，药物标签，监查员资质和药检报告等；医疗器械临床试验的问题位居前几位的分别是PI的GCP证书时限，监查员资质，申办者资质和检验报告等。 结论 建议行业内部出台临床试验立项审查要点指导性文件，加强机构与申办者及CRO的沟通交流，加强对相关人员的培训，从而共同促进临床试验立项审查的质量和效率。 Objective As China′s new drug review and approval system continues to evolve, clinical trial management procedures are being continuously promoted and refined. This article aims to identify key review points for clinical trial establishment reviews and offer recommendations for optimizing the review process. Methods By combining the regulatory requirements for clinical trial establishment management and the unique situation of our institution, the status of establishment approval applications upon initial submission and challenges encountered during establishment approval reviews were analyzed. The factors that may affect the likelihood of initial approval for establishment applications, and the elements and standards involved in clinical trial establishment approval reviews were studied. Results From 2020 to 2022, the hospital received a total of 514 clinical trial establishment applications for registration purposes, with a first-time approval rate of 30.2%.Whether an application served as a team leader unit or a single-center clinical trial significantly impacted its likelihood of initial approval (P<0.05). In clinical trial establishment reviews, drug clinical trials were most commonly associated with issues regarding sponsor qualifications, drug labeling, CRA qualifications, and drug testing reports. For medical device clinical trials, the most common issues were related to PI GCP certificate expiration dates, CRA qualifications, sponsor qualifications, and inspection reports. Conclusions To enhance the quality and efficiency of clinical trial establishment reviews, it is recommended that trade organizations publish guidance documents on key points for clinical trial establishment reviews. Additionally, it is essential to enhance communication and collaboration among institutions, sponsors, and CROs and provide more training for relevant personnel, to jointly promote a more streamlined and effective clinical trial establishment review process.

    临床试验立项审查审查要点

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    医疗卫生机构科技成果作价投资的模式探索

    张炜王慧云陶庆梅于新颖...
    34-38页
    查看更多>>摘要：目的 针对医院科技成果作价投资的操作模式进行分析，以期为其它医疗卫生机构开展科技成果作价投资提供一定的借鉴和参考。 方法 本文分析了科技成果作价投资的起源及现行状况，以北京大学肿瘤医院为例，对科技成果作价投资模式进行深入的解析。 结果 研究发现医疗卫生机构科技成果作价投资包括签订作价投资协议、签订股东协议和公司章程、技术合同的登记认定及发票开具、递延纳税等几个关键环节，并对如何应用这一模式进行科技成果转化提出了几点建议。 结论 科技成果作价投资尽管实施过程繁琐、操作模式多样、股权归属难分，但优势极为明显。它能使技术资本和产业资本紧密结合，形成牢固、有效的技术联盟和多方利益共同体，更好地运用科技创新市场化动机，开展契合市场前景的前沿性研究。 Objective Analyze the operation mode of the valuation investment of scientific and technological achievements in hospitals, and provide a certain reference for other hospitals to carry out valuation investment in scientific and technological achievements. Methods This paper analyzed the origin and current situation of the valuation investment of scientific and technological achievements. Taking Peking University Cancer Hospital as an example, it made an in-depth analysis of the valuation investment model of scientific and technological achievements. Results The study found that the valuation investment of scientific and technological achievements in hospitals includes several key links such as signing the Valuation Investment Agreement, signing the Shareholder Agreement and the Articles of Association, the registration and identification of technical contracts, the issuance of invoices, and deferred taxation. And several suggestions on how to apply this model for the transformation of scientific and technological achievements were put forward. Conclusions Although the implementation process of scientific and technological achievements is cumbersome, the operation mode is diverse, and the ownership of equity is difficult to distinguish, the advantages are extremely obvious. It can closely combine technological capital and industrial capital, form a strong and effective technological alliance and a community of multiple interests, better use the market-oriented motivation of scientific and technological innovation, and carry out cutting-edge research in line with market prospects.

    医疗卫生机构科技成果作价投资科技成果转化

      原文链接:
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    首都卫生发展科研专项成果综合评价研究

    薛恩慈芦欣怡王雪莹曾琳...
    39-44页
    查看更多>>摘要：目的 针对临床医学问题设立的首都卫生发展科研专项(简称"首发专项")已运行十余年。本研究旨在追踪并综合评价该基金项目的成果产出情况，为优化临床研究基金的运作模式提供实证支持与建议。 方法 通过在线问卷对首发专项已经结题的1051项课题的所属学科领域、负责人情况、衍生项目、论文、专利、成果转化、成果普及推广等方面进行调查。 结果 在线调查共收集到745项课题，对极端值进行复核后最终纳入720个结题项目。结题数目排序前3位的学科领域分别是肿瘤、心血管疾病和神经系统疾病；项目负责人年龄呈左偏态分布，中位年龄为45岁；319个(44%)项目后续得到了其他相关项目的支持；684个(95%)的项目发表了论文；211个(29%)项目申请了专利及著作权，141个获得了专利授权；78个(11%)项目完成了科技成果的转化，转化方式以转让和许可较多；临床诊疗指标改善中以治疗为主，诊断次之；156个(22%)项目的成果进行了普及推广，成果多推广到二级医院和社区卫生机构。 结论 首发专项学科设置符合当地实际需要，成果产出颇丰。未来，可考虑建立临床研究的综合评价机制，加大推进高质量成果产出力度，加强项目指南设定的组织模式，并进一步完善滚动支持机制。 Objective The Capital′s Funds for Health Improvement and Research (referred to as ″CFH″), established to address clinical medical issues, have been operating for over a decade. This study aims to comprehensively evaluate the achievements of this fund and provide empirical support and recommendations for optimizing the operational model of the clinical research fund. Methods An online questionnaire was used to investigate the following aspects of CFH: subject area, the person in charge, derived projects, theses, patents, transformation of results, and popularization and promotion. Results A total of 745 projects were collected through the online survey, and after rechecking for outliers, 720 completed projects were ultimately included. The top three disciplinary domains, in terms of the number of completed projects, were oncology, cardiovascular diseases, and neurological disorders. The age distribution of project leaders exhibited a left-skewed pattern, with a median age of 45 years. 319 (44%) received support from other related projects subsequently. 95% of the projects resulted in paper publication. 211 (29%) projects applied for patents and copyrights, with 141 projects being granted patent authorization. 78 (11%) projects successfully achieved technology transfer, with transfer and licensing being the most common modes. 156 (22%) projects disseminated their outputs, often targeting secondary hospitals and community health institutions. Conclusions CFH aligns with local needs, and the outputs are substantial. In the future, consideration can be given to establishing an evaluation mechanism, increasing efforts to promote high-quality outputs, strengthening the organizational model set by the project guidelines, and further improving the rolling support mechanism.

    科研基金资助科研产出评价科研管理

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    医院专利及成果转化管理问题与对策

    李浩王有俊孙心岩
    45-49页
    查看更多>>摘要：目的 以上海交通大学医学院附属上海儿童医学中心专利及成果转化管理经验为例，探讨医院知识产权和成果转化管理创新举措。 方法 对医院自建院以来专利授权、维护及转化数据进行统计分析，了解专利管理及成果转化情况，分析现存问题，并探讨解决策略。 结果 医院发明专利和实用新型专利5年内维持率分别为92.31%和88.24%，转化率分别为3.92%和0.56%，平均维持时长为3.06年和2.99年。失效的发明专利全部因未缴年费而专利权终止。截至2033年，医院维持全部专利的费用预计从2023年的2.00万元增长到3.54万元。 结论 专利权维持度不高、成果转化缺乏、技术许可未登记是该院科技成果管理中存在的主要问题。未来应加大专利申请和维持的支持力度，加强科技成果转化推进工作，做好技术许可登记备案，以营造良好的知识产权及成果转化氛围，逐步培育高价值专利并做好成果转化工作。 Objective Taking the experience of patent and achievement transformation management at the Shanghai Children's Medical Center affiliated with Shanghai Jiao Tong University School of Medicine as a reference, to explore the innovative strategies for hospital intellectual property and achievement transformation management. Methods An in-depth statistical analysis was conducted on the patent authorization, maintenance, and transformation data of the institute since its inception, to gain a comprehensive understanding of the current state of patent management and achievement transformation, identify prevalent issues, and propose potential solutions. Results The maintenance rates of invention patents and utility model patents within 5 years were 92.31% and 88.24% respectively, while the conversion rates were 3.92% and 0.56% respectively, with an average duration of maintenance of 3.06 years and 2.99 years. All expired invention patents were terminated due to unpaid annual fees. By 2033, the cost of maintaining all patents at the institute is expected to rise from 20 000 yuan in 2023 to 35 400 yuan. Conclusions The key challenges in managing scientific and technological achievements at the institute include low patent maintenance rates, limited achievement transformation, and the absence of registered technology licenses. In the future, it is suggested to enhance the support for patent application and maintenance, promote scientific and technological achievement transformation, ensure effective technology license registration and filing, gradually cultivate a positive atmosphere for intellectual property and achievement transformation, cultivate high-value patents, and prioritize effective achievement transformation.

    医院专利成果转化

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    三级公立医院个人科研绩效考核应用实践分析

    丁雯朱依滢毛建华舒强...
    50-57页
    查看更多>>摘要：目的 应用实施个人科研绩效考核，发现医院发展过程中的优势及短板，为医院科技政策制定提供依据。 方法 构建医院科研绩效考核系统，连续3年在全院范围内分类开展个人科研绩效考核。对个人考核结果进行深入分析，采用多样本秩和检验，分析年度间、系列间考核得分整体水平是否存在差异。采用两样本秩和检验，分析晋升与非晋升组间是否存在差异。采用χ2检验，分析年龄、学位、性别和生育情况是否影响考核等级。 结果 2020—2022年，个人科研绩效考核得分呈整体上升趋势，人均考核得分从35.26分大幅提高至74.04分。不同职称人员考核得分存在着统计学差异，科研业绩呈现正高>副高>中级。晋升与非晋升组间不存在着统计学差异。 结论 初步证明，个人科研绩效考核能有效引导科研人员科技创新活动，在提高医院整体科研实力中起到了积极作用。数据分析结果提示，通过紧抓新入职博士学位人员、建立"传帮带"形式帮扶指导制度、给予女性研究人员倾斜支持政策，有望持续提升医院科研业绩。考核结果为管理部门提供了一把"量尺"，为科技政策制定提供了数据支撑。 Objective To identify the strengths and weaknesses of hospital development through the application of individual scientific research performance assessment, thereby providing a basis for the formulation of science and technology policies. Methods We established a research performance assessment system and conducted research performance assessments across the hospital for three consecutive years. The assessment results were analyzed in-depth, utilizing the Kruskal-Wallis test to determine if there were differences in the overall level of assessment scores between years and series the Mann-Whitney test to analyze differences between the promoted and non-promoted groups the χ2 test to analyze whether age, degree, gender, and maternity situations affected assessment grades. Results From 2020 to 2022, the individual scientific research performance assessment scores showed an overall upward trend, with the average per capita assessment score increasing significantly from 35.26 points in 2020 to 74.04 points in 2022. There were statistical differences in the assessment scores of different professional titles, indicating that the senior professionals > the associate senior professionals > the intermediates. There was no significant difference between the promoted and non-promoted groups. Additionally, age, degree, gender, and maternity factors affected assessment grades. Conclusions It has been preliminarily established that the assessment of individual scientific research performance can effectively steer the scientific innovation activities of researchers, and play a positive role in enhancing the overall scientific research strength. The findings from the data analysis indicate that the hospital is expected to continuously enhance its scientific research performance by focusing on newly recruited doctoral personnel, establishing a system of support and guidance, and providing preferential support to female researchers. The assessment results serve as a " benchmark" for management departments and provide data-driven insights for the development of science and technology policies.

    科研绩效考核考核指标评价标准管理策略

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