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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Detalles Bibliográficos
Autores principales: Jalgaonkar, Sharmila V., Bhide, Shruti S., Tripathi, Raakhi K., Shetty, Yashashri C., Marathe, Padmaja A., Katkar, Janhavi, Thatte, Urmila M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4703381/
https://www.ncbi.nlm.nih.gov/pubmed/26735850
http://dx.doi.org/10.1371/journal.pone.0146334

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4703381/
https://www.ncbi.nlm.nih.gov/pubmed/26735850
http://dx.doi.org/10.1371/journal.pone.0146334

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