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trial subject
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  试点课题
     Several Problems in the Research of Distance Education Science -On TVU' s Trial Subject Research and its Conclusion
     远程教育科学研究工作的几个问题——兼论电大试点课题研究及结题工作
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  “trial subject”译为未确定词的双语例句
     In section two, firstly, it explores the theory of inter-subjectivity, and secondly it explores the accuse subject, the defense subject and the trial subject in the perspective of perspective of procedure structure.
     第二节首先解读了主体间性理论,之后以诉讼构造为视角分析了控诉权、辩护权以及裁判权主体,并且分析了各主体在纵向构造中的关系,最后分析了各主体在横向构造中的关系;
短句来源
     One trial subject still happened allergic reactions. The rate of allergic reactions was 0.43%.
     皮试阴性者参加临床试验,但两组仍有1例发生过敏反应,发生率为0.43%。
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  相似匹配句对
     On "Subject"
     论“主语”
短句来源
     the subject;
     挪用公款罪的主体;
短句来源
     Informed Consent and Human Subject Trial
     知情同意与人体试验
短句来源
     Trial Remark on the Supreme Subject of Marxism
     试论马克思主义的最高命题
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     on-the-spot trial;
     平政院可就地审判;
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  trial subject
Below each question the trial subject had five options to select from.
      


An intervention study was conducted in 75 young children under one year hospitalized with pneumonia or bronchiolitis caused by respiratory syncytial virus (RSV) to evaluate therapeutic effectiveness of selenium (Se) supplement on acute respiratory lower tract infection caused by RSV with randomly controlled and doublemasked method. Trial subjects were divided into two groups, one with 37 children in routine treatment and the other with 38 children in routine treatment plus Se supplement. The control group...

An intervention study was conducted in 75 young children under one year hospitalized with pneumonia or bronchiolitis caused by respiratory syncytial virus (RSV) to evaluate therapeutic effectiveness of selenium (Se) supplement on acute respiratory lower tract infection caused by RSV with randomly controlled and doublemasked method. Trial subjects were divided into two groups, one with 37 children in routine treatment and the other with 38 children in routine treatment plus Se supplement. The control group derived from 35 normal children during their physical checkup in the outpatient department. Sodium selenite was supplemented orally with 1 mg on the second day of hospitalization. Results showed that days needed for their relief of symptoms and signs were fewer in Se supplement group than that in controls and recovery in indicators of cell immune was better in the former than that in the latter. Levels of Se and glutathione peroxidase in plasma and white cells could be increased by Se supplement. It suggests that Se supplement can promote recovery from RSV infection.

为评价补硒对呼吸道合胞病毒(RSV)所致急性下呼吸道感染的疗效,采用双盲随机对照法,对75例1岁以下RSV感染的肺炎或毛细支气管炎住院患儿进行干预研究。结果表明,补硒组在症状、体征缓解天数方面短于常规治疗组,细胞免疫指标恢复正常者较常规治疗组多。补硒使血浆和白细胞中硒和谷胱甘肽过氧化物酶水平显著增高。本研究结果提示补硒可促进该病的恢复

With the issue and practice of Good Clinical Practice (GCP) in China,great progress has been made.However,we should also notice that the overall clinical trial levels still lag behind the requirements of GCP.For instance,there are still many gaps and problems in the protection of human subjects' rights and benefits.In GCP there are some articles concerning the protection of human subjects,but there are also problems in present clinical trials.For example,some trial designs are not...

With the issue and practice of Good Clinical Practice (GCP) in China,great progress has been made.However,we should also notice that the overall clinical trial levels still lag behind the requirements of GCP.For instance,there are still many gaps and problems in the protection of human subjects' rights and benefits.In GCP there are some articles concerning the protection of human subjects,but there are also problems in present clinical trials.For example,some trial designs are not approved by Ethics Committee,the trial subjects have no access or inadequate access to the information related to the clinical trial and some subjects are even involved in the trial without giving informed content.In order to protect the benefits and rights of trial subjects,China has adopted the many measures.For instance,to establish the GCP training centers so as to provide regular training for the clinical trial investigatiors,doctors,pharmacists and sponsors,to set up the system for the checkup the trial bases,to protect trial subjects' benefits and rights by legal means.

随着国家《药品临床试验管理规范》的颁布与实施 ,我国新药临床试验研究水平有相当的提高 ,但也存在着一些问题 ,其中包括保护受试者权益问题。国家GCP有关章节中明确指出要保护受试者权益 ,并有具体规定 ,但在执行中尚有出入。如试验方案未经伦理委员会批准、未向受试者告知试验内容 ,或告知的不够充分、甚至在未签署知情同意书时就开始试验等。为此 ,我国采取了相应的措施 ,如设立药品临床研究培训中心 ;定期对临床试验基地的研究者以及相关人员如与试验有关的医师、药师及申办者进行GCP培训、基地审核制度 ,以法律手段来保证受试者权益等。

Standard Operating Procedures (SOP) of clinical investigators are established according to SFDA, ICH and WHO Good Clinical Practice standards, and experiences of clinical trials practice in our hospital. It includes qualification and competence of investigators, prior to initiation of the study, screening and recruitment of study subjects, obtain informed consent from all trial subjects, protocol compliance, provide medical care for trial subjects, randomization procedures and unblinding,...

Standard Operating Procedures (SOP) of clinical investigators are established according to SFDA, ICH and WHO Good Clinical Practice standards, and experiences of clinical trials practice in our hospital. It includes qualification and competence of investigators, prior to initiation of the study, screening and recruitment of study subjects, obtain informed consent from all trial subjects, protocol compliance, provide medical care for trial subjects, randomization procedures and unblinding, safety reporting, source data/document, case report forms, product management, premature termination or suspension of a trial, progress and final reports, and investigator’s files.

依据SFDA《药品临床试验管理规范》 ,ICHGCP ,WHOGCP ,以及我院临床试验的实践 ,制订临床试验机构研究者的标准操作规程 ,包括研究者资格与条件 ,试验前的准备 ,受试者的招募和筛选 ,受试者的知情同意 ,方案的依从性 ,受试者的医疗 ,随机化程序和破盲 ,安全性报告 ,源文件和源数据 ,病例报告表 ,试验用药的管理 ,试验的终止或暂停 ,进展报告和总结报告 ,档案等。

 
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