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Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission

Overview of attention for article published in PLOS ONE, November 2012
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Title
Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission
Published in
PLOS ONE, November 2012
DOI 10.1371/journal.pone.0048906
Pubmed ID
Authors

Gianfranco De Feo, Giacomo Chiabrando, Nunzia Cannovo, Antonio Galluccio, Carlo Tomino

Abstract

The high variability of "centre-specific" documentation required by Independent Ethics Committee (IEC) plays a role in the time required for activation of participating centres of multicentre clinical trials. This study (a) provides a picture of the different activities, structural requirements and resources dedicated to the operation of the local IEC in Italy; (b) defines a detailed list of "centre-specific" documents considered as essential by the IEC for issuing its opinion and (c) suggests a "single document" to reduce the variability of the "centre-specific" documents required by the IEC.

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Geographical breakdown

Country Count As %
Unknown 4 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 1 25%
Student > Bachelor 1 25%
Researcher 1 25%
Student > Doctoral Student 1 25%
Readers by discipline Count As %
Philosophy 1 25%
Business, Management and Accounting 1 25%
Medicine and Dentistry 1 25%
Engineering 1 25%