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名词解释题
药物临床试验（drug clinical trial）
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境外申请人临床试验用药物应当是已在境外注册的药品或者已进入（ ）。A．Ⅱ期或者Ⅲ期临床试验的药物B．Ⅰ期或者Ⅳ期临床试验的药物C．Ⅰ期或者Ⅲ期临床试验的药物D．Ⅱ期临床试验的药物E．Ⅰ期临床试验的药物
考题
治疗药物监测的英文是()
A.therapeutic drug monitoringB.treatment drug monitoringC.drug concentration monitoringD.drug therapy monitoring
考题
下列关于GCP叙述错误的是A、GCP即为药物临床试验管理规范B、是指任何在人体(特指患者)进行的药品系统性研究C、目的在于保证临床试验过程的规范D、可揭示试验用药品的作用和不良反应等E、是Good Clinical Practice的简称
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共用题干
Clinical Trials1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.3. The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective（预期的）participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating. Paragraph 2______A: Are clinical trials safe?B: What are clinical trials?C: What should people know before participating in a clinical trial?D: Who should consider clinical trials and why?E: Where are clinical trials conducted?F: Why are clinical trials done?
考题
共用题干
Clinical Trials1 Many clinical trials are done to see if a new drug or device is safe and effective for people to use .Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects. Sometimes,studies are done to learn how to best use the treatment in a different group, such as children,in whom the treatment was not previously tested.2 It is important to test drugs and medical products in the people they are meant to help,It is also important to conduct research in a variety of people because different people mayrespond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options.Other people participate in trials because they want to contribute to the advancement of medical knowledge.3 The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial. Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.4 People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of thehealth care team. Prospective（预期的）participants should understand what happens during the trial,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating. Reliable information should be available to_________.A: for some patientsB: before participationC: in humansD:medical knowledgeE: during the trialF: candidates for clinical trials
考题
共用题干
Clinical Trials1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.3. The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective（预期的）participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating. Learn as much as you can about a clinical trial______.A: candidates for clinical trialsB: during the trialC: medical knowledgeD: in humansE: before participationF: for some patients
考题
共用题干
Clinical Trials1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.3. The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective（预期的）participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating. Clinical trials provide the only hope______.A: candidates for clinical trialsB: during the trialC: medical knowledgeD: in humansE: before participationF: for some patients
考题
下列关于GCP叙述错误的是A.GCP即为药物临床试验管理规范
B.目的在于保证临床试验过程的规范
C.是Good Clinical Practice的简称
D.是指任何在人体(特指患者)进行的药品系统性研究
E.可揭示试验用药品的作用和不良反应等
考题
药物临床试验是指任何在人体进行的药物系统性研究，以证实或揭示试验药物的作用，临床试验分为四期药物治疗作用确证阶段属于A、Ⅱ期临床试验
B、Ⅰ期临床试验
C、Ⅲ期临床试验
D、Ⅳ期临床试验
考题
中药材种植单位必须执行（）A、GAP中药材生产质量管理规范B、GLP药物非临床研究质量管理规范C、GCP药品临床试验管理规范（Good Clinical Practice,GCP）D、GMP药品生产质量管理规范药品经营质量管理规范
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关于《药物临床试验质量管理规范》和《药物临床试验管理质量规范》，下列哪项不正确（）A、《药物临床试验质量管理规范》是有关临床试验的准则B、《药物临床试验管理质量规范》是有关临床试验的技术标准C、《药物临床试验管理质量规范》是关于临床试验方案设计、组织实施、监查、审视、记录、分析、总结和报告标准D、《药物临床试验质量管理规范》是临床试验全过程的标准
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在Pubmed中检索有关“感冒的药物治疗”的循证医学文献，最佳途径为（）A、Search （Common Cold and drug therapy）B、Search （Common Cold and drug therapy） Limits：Systematic ReviewsC、Search （Common Cold /drug therapy） Limits：Systematic ReviewsD、Search （Common Cold and drug therapy and EBM）
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单选题关于《药物临床试验质量管理规范》和《药物临床试验管理质量规范》，下列哪项不正确（）A
《药物临床试验质量管理规范》是有关临床试验的准则B
《药物临床试验管理质量规范》是有关临床试验的技术标准C
《药物临床试验管理质量规范》是关于临床试验方案设计、组织实施、监查、审视、记录、分析、总结和报告标准D
《药物临床试验质量管理规范》是临床试验全过程的标准
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