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Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study

BACKGROUND: According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs t...

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Detalles Bibliográficos
Autores principales:	Brosteanu, Oana, Schwarz, Gabriele, Houben, Peggy, Paulus, Ursula, Strenge-Hesse, Anke, Zettelmeyer, Ulrike, Schneider, Anja, Hasenclever, Dirk
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	SAGE Publications 2017
Materias:	Data Management and Trial Conduct
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5718334/ https://www.ncbi.nlm.nih.gov/pubmed/28786330 http://dx.doi.org/10.1177/1740774517724165

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