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Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

BACKGROUND: Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC revie...

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Detalles Bibliográficos
Autores principales: van Lent, Marlies, Rongen, Gerard A, Out, Henk J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4269968/
https://www.ncbi.nlm.nih.gov/pubmed/25490963
http://dx.doi.org/10.1186/1472-6939-15-83