临床实践指南(clinical practice guideline)
临床实践指南(clinical practice guideline)
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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
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?
In modern clinical practice, doctors personally assess patients in order to ______, treat, and prevent disease using clinical judgment.A.remedyB.diagnoseC.infectD.judge
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
冠心病监护病房为()。A、intensive care unitB、coronary care unitC、acute myocardial infarctionD、Clinical common crisisE、Clinical Intensive Care
多选题二次证据包括以下哪几种?()A系统评价B随机对照试验C临床实践指南DMeta分析