Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials

AIM: The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach. METHODS: We used data from three randomized phase III tr...

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Detalhes bibliográficos
Publicado no:Br J Clin Pharmacol
Main Authors: Andersen, Jeppe Ragnar, Byrjalsen, Inger, Bihlet, Asger, Kalakou, Faidra, Hoeck, Hans Christian, Hansen, Gitte, Hansen, Henrik Bo, Karsdal, Morten Asser, Riis, Bente Juel
Formato: Artigo
Idioma:Inglês
Publicado em: Blackwell Science Inc 2015
Assuntos:
Methods in Clinical Pharmacology
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4386950/
https://ncbi.nlm.nih.gov/pubmed/25327707
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.12531
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