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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...

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Detalles Bibliográficos
Autores principales: Ferran, Jean-Marc, Nevitt, Sarah J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
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