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Unreported protocol deviations – The tip of the research-berg

INTRODUCTION: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often miss...

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Detalles Bibliográficos
Autores principales: Kulkarni, Uma, Vaswani, Ravi, Guthigar, Mohammed, Bhat, Nagapati, Sonde, Laxminarayan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267994/
https://www.ncbi.nlm.nih.gov/pubmed/37325575
http://dx.doi.org/10.4103/picr.picr_235_21