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Regulatory Compliance Requirements for an Open Source Electronic Image Trial Management System
There is a global need for software to manage imaging based clinical trials to speed basic research and drug development. Such a system must comply with regulatory requirements. The U.S. Food and Drug Administration (FDA) has regulations regarding software development process controls and data prove...
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| Publicado no: | Conf Proc IEEE Eng Med Biol Soc |
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| Main Authors: | , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2010
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4559082/ https://ncbi.nlm.nih.gov/pubmed/21097264 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1109/IEMBS.2010.5627838 |
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