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Principles and procedures for data and safety monitoring in pragmatic clinical trials

BACKGROUND: All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and traditional explanatory clinical trials. METHODS/R...

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Detalles Bibliográficos
Autores principales:	Simon, Gregory E., Shortreed, Susan M., Rossom, Rebecca C., Penfold, Robert B., Sperl-Hillen, Jo Ann M., O’Connor, Patrick
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2019
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902512/ https://www.ncbi.nlm.nih.gov/pubmed/31815644 http://dx.doi.org/10.1186/s13063-019-3869-3

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