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

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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Bibliographic Details
Main Authors: Sharmila V Jalgaonkar, Shruti S Bhide, Raakhi K Tripathi, Yashashri C Shetty, Padmaja A Marathe, Janhavi Katkar, Urmila M Thatte
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2016-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4703381?pdf=render

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http://europepmc.org/articles/PMC4703381?pdf=render

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