| What is a clinical trial protocol? | |
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MedLine Citation:
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PMID: 20815294 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards. |
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Authors:
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Andrea Cipriani; Corrado Barbui |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Epidemiologia e psichiatria sociale Volume: 19 ISSN: 1121-189X ISO Abbreviation: Epidemiol Psichiatr Soc Publication Date: 2010 Apr-Jun |
Date Detail:
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Created Date: 2010-09-06 Completed Date: 2010-11-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9501447 Medline TA: Epidemiol Psichiatr Soc Country: Italy |
Other Details:
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Languages: eng Pagination: 116-7 Citation Subset: IM |
Affiliation:
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Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Italy. andrea.cipriani@univr.it |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Protocols* Clinical Trials as Topic / standards* Humans |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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