超星 - Test 11 - 查题吧

判断题

TheDeclarationofHelsinki(2013,Article15)byWMAdeclaresthat,"Appropriatecompensationandtreatmentforsubjectswhoareharmedasaresultofparticipatinginresearchmustnotbeensured".

A. 对
B. 错

判断题

TheDeclarationofHelsinki(2013,Article19)byWMAdeclaresthat,"Some groups and individuals are particularly vulnerable and may have an decreased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection".

A. 对
B. 错

判断题

TheDeclarationofHelsinki(2013,Article 20)byWMAdeclaresthat,"Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should not stand to benefit from the knowledge, practices or interventions that result from the research".

A. 对
B. 错

判断题

TheDeclarationofHelsinki(2013,Article27)byWMAdeclaresthat,"When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely dependent of this relationship".

A. 对
B. 错

判断题

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, China, & the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

A. 对
B. 错

判断题

Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question.

A. 对
B. 错

判断题

Infomed consent is a process by which a subject unvoluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

A. 对
B. 错

判断题

Clinical trials generate data on safety and efficacy. Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients may not be approved by a supervising ethics committee before permission is granted to run the trial.

A. 对
B. 错

判断题

A protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.

A. 对
B. 错

判断题

Clinical study is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

A. 对
B. 错

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