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Good clinical practice regulatory inspections: Lessons for Indian investigator sites
Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs), protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investi...
| Autores principales: | , , |
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| Formato: | Texto |
| Lenguaje: | English |
| Publicado: |
Medknow Publications
2010
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043366/ https://www.ncbi.nlm.nih.gov/pubmed/21350732 http://dx.doi.org/10.4103/2229-3485.71776 |