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Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials
The classification system for categorizing the riskiness of a clinical trial is largely defined by the body of federal regulations known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration (FDA) codified in 21 CFR 50. This rule is applied accord...
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| Publicado no: | Clin Trials |
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| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4703320/ https://ncbi.nlm.nih.gov/pubmed/26374686 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1740774515597687 |
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