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[Good clinical practice].

Authors: H, Mix; J, Marovac;

[Good clinical practice].

Abstract

Good clinical practice is the pattern of international standards to assure ethical and scientific quality in the design, conduction and report of studies that involve human beings. These standards are applied in pharmaceutical research, since they came out as regulations to register new medications. Nowadays, they are accepted as standard procedures in clinical research. They are enforced in developed countries since more than a decade and are currently being implemented in Latin America, thanks to an initiative of the pharmaceutical industries. The saturation and high costs of clinical research in Europe and United States, render Latin America as a potential region to conduct clinical studies. FDA, Europe and Japan accept data from abroad, if the studies are conducted following the norms of good clinical practice. It is therefore important that Chilean research centers and researchers become familiar with these norms and be prepared for their implementation.

Related Organizations
Keywords

Ethics Committees, Human Experimentation, Informed Consent, Clinical Protocols, Research, Humans, Ethics, Medical

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Average
Average
gold