Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency

BACKGROUND: Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplemen...

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Detalles Bibliográficos
Autores principales: Hamilton, Samina, Bernstein, Aaron B., Blakey, Graham, Fagan, Vivien, Farrow, Tracy, Jordan, Debbie, Seiler, Walther, Shannon, Anna, Gertel, Art
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Methodology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5794039/
https://www.ncbi.nlm.nih.gov/pubmed/29451540
http://dx.doi.org/10.1186/s41073-016-0009-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5794039/
https://www.ncbi.nlm.nih.gov/pubmed/29451540
http://dx.doi.org/10.1186/s41073-016-0009-4

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