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An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: a pilot study

In Perspectives in Clinical Research
By: Bhowmick S.
Contributor(s): Banerjee K | kolkataresearcher@gmail.com | Sikdar S.
Material type: materialTypeLabelArticleSeries: Vol 5 Issues 3.Publisher: 2014Description: 115-120.Subject(s): Attitude, Eastern India, Institutional Ethics Committee, knowledge, pharmacovigilance, practice | DDC classification: Online resources: Click here to access online In: Perspectives in Clinical ResearchSummary: Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to a
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Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to a

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