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A Systematic Review of Federal Drug Administration Docket for Community Consultation and Public Disclosure in Exception from Informed Consent Trials
BACKGROUND: Exception from informed consent imposes community consultation and public disclosure requirements on clinical investigation in critically ill and injured patients. In 2011, the Food and Drug Administration (FDA) instructed sponsors to submit publically disclosed information to the FDA Do...
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| Publicat a: | Clin Trials |
|---|---|
| Autors principals: | , , , |
| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
2017
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| Matèries: | |
| Accés en línia: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5799022/ https://ncbi.nlm.nih.gov/pubmed/29039683 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1740774517737318 |
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