Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigat...

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Detalles Bibliográficos
Autores principales: Kramer, Judith M., Vock, David, Greenberg, Howard E., Janning, Cheri, Szczech, Lynda, Salgo, Miklos, Gagnon, Suzanne, Ellenberg, Susan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2014
Materias:
Safety
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4230957/
https://www.ncbi.nlm.nih.gov/pubmed/25419504
http://dx.doi.org/10.1177/2168479013520160

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