| Current clinical research environment: focus on psychiatry. | |
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MedLine Citation:
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PMID: 17713687 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area. |
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Authors:
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Sonia Mansoldo Dainesi; Helio Elkis |
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Publication Detail:
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Type: Journal Article Date: 2007-09-18 |
Journal Detail:
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Title: Revista brasileira de psiquiatria (São Paulo, Brazil : 1999) Volume: 29 ISSN: 1516-4446 ISO Abbreviation: Rev Bras Psiquiatr Publication Date: 2007 Sep |
Date Detail:
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Created Date: 2007-09-24 Completed Date: 2008-04-24 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100895975 Medline TA: Rev Bras Psiquiatr Country: Brazil |
Other Details:
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Languages: eng Pagination: 283-90 Citation Subset: IM |
Affiliation:
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Núcleo de Apoio à Pesquisa Clínica, Hospital das Clínicas, Medical School, Universidade de São Paulo, São Paulo, SP, Brazil. sonia.dainesi@hcnet.usp.br |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Biomedical Research
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ethics,
standards*,
statistics & numerical data Brazil Clinical Trials as Topic / ethics, standards* Conflict of Interest Guideline Adherence Humans Information Services / organization & administration* International Cooperation Multicenter Studies as Topic National Health Programs Practice Guidelines as Topic Psychiatry* Registries* Research Design |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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