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Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital

BACKGROUND: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the ext...

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Detalles Bibliográficos
Autores principales: Dakhale, Ganesh Nathuji, Kalikar, Mrunalini Vinay, Giradkar, Akhil B., Sinha, Vishakha V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635352/
https://www.ncbi.nlm.nih.gov/pubmed/36337370
http://dx.doi.org/10.4103/picr.PICR_293_20