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Assessment and classification of protocol deviations
INTRODUCTION: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. METHODS: A new method has been proposed by which deviations are classified in five grades from 1...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Medknow Publications & Media Pvt Ltd
2016
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936072/ https://www.ncbi.nlm.nih.gov/pubmed/27453830 http://dx.doi.org/10.4103/2229-3485.184817 |