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An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital

Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectiv...

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Detalhes bibliográficos
Publicado no:PLoS One
Main Authors: Jalgaonkar, Sharmila V., Bhide, Shruti S., Tripathi, Raakhi K., Shetty, Yashashri C., Marathe, Padmaja A., Katkar, Janhavi, Thatte, Urmila M.
Formato: Artigo
Idioma:Inglês
Publicado em: Public Library of Science 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4703381/
https://ncbi.nlm.nih.gov/pubmed/26735850
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pone.0146334
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