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- Q5403463 subject Q8425101.
- Q5403463 abstract "The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.With the Clinical Trials Directive, the European Union (EU) envisioned a harmonisation of research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account.".
- Q5403463 wikiPageExternalLink dir200120ec.htm.
- Q5403463 wikiPageExternalLink bioethics_ethics_en.htm.
- Q5403463 wikiPageExternalLink Dir2001-20_en.pdf.
- Q5403463 wikiPageExternalLink ethicscommittees.
- Q5403463 wikiPageExternalLink www.nres.npsa.nhs.uk.
- Q5403463 wikiPageExternalLink documents.php.
- Q5403463 wikiPageWikiLink Q11070800.
- Q5403463 wikiPageWikiLink Q130146.
- Q5403463 wikiPageWikiLink Q2151374.
- Q5403463 wikiPageWikiLink Q2151392.
- Q5403463 wikiPageWikiLink Q30612.
- Q5403463 wikiPageWikiLink Q362104.
- Q5403463 wikiPageWikiLink Q367158.
- Q5403463 wikiPageWikiLink Q458.
- Q5403463 wikiPageWikiLink Q573538.
- Q5403463 wikiPageWikiLink Q682667.
- Q5403463 wikiPageWikiLink Q764527.
- Q5403463 wikiPageWikiLink Q8425101.
- Q5403463 wikiPageWikiLink Q9180065.
- Q5403463 comment "The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.With the Clinical Trials Directive, the European Union (EU) envisioned a harmonisation of research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account.".
- Q5403463 label "Ethics committee (European Union)".