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European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research
BACKGROUND: Clinical study reports (CSRs) have been increasingly utilised within academic research in recent years. European Medicines Agency (EMA) Policy 0070 ‘Phase 1,’ which came into effect in January 2015, requires the publication of regulatory documents such as CSRs from central applications i...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2019
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6833240/ https://www.ncbi.nlm.nih.gov/pubmed/31690260 http://dx.doi.org/10.1186/s12874-019-0836-3 |