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Hybrid approaches to clinical trial monitoring: Practical alternatives to 100% source data verification

For years, a vast majority of clinical trial industry has followed the tenet of 100% source data verification (SDV). This has been driven partly by the overcautious approach to linking quality of data to the extent of monitoring and SDV and partly by being on the safer side of regulations. The regul...

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Detalles Bibliográficos
Autor principal: De, Sourabh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications Pvt Ltd 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159208/
https://www.ncbi.nlm.nih.gov/pubmed/21897885
http://dx.doi.org/10.4103/2229-3485.83226