Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

BACKGROUND/AIMS: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transfo...

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Detalles Bibliográficos
Autores principales: Perez, Raymond, Archdeacon, Patrick, Roach, Nancy, Goodwin, Robert, Jarow, Jonathan, Stuccio, Nina, Forrest, Annemarie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2017
Materias:
Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5560478/
https://www.ncbi.nlm.nih.gov/pubmed/28345368
http://dx.doi.org/10.1177/1740774517700640

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5560478/
https://www.ncbi.nlm.nih.gov/pubmed/28345368
http://dx.doi.org/10.1177/1740774517700640

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