Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical tria...
Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
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Publisher
England: BioMed Central
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Language
English
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England: BioMed Central
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We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and proced...
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Full title
Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
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TN_cdi_doaj_primary_oai_doaj_org_article_89241f1a85d5453ba0404500226b0444
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https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_doaj_primary_oai_doaj_org_article_89241f1a85d5453ba0404500226b0444
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ISSN
1472-6939
E-ISSN
1472-6939
DOI
10.1186/s12910-021-00618-2
