Impact of Educational Intervention on Knowledge, Attitude and Awareness of Good Clinical Practice among Health Care Providers
Journal Title: IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) - Year 2019, Vol 18, Issue 3
Abstract
Introduction: Clinical trials play an important role in the generation of evidence-based data in health care practices. To ensure the credibility of data and the safety and well-being of the patients Good clinical practice (GCP) guidelines play an important role. The present study intends to assess health care professionals’ knowledge, perception, and attitude towards compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines in basic aspects of conduct of clinical trial and associated regulatory as well as ethical issues before and after the educational intervention in form of a workshop on Good Clinical Practice (GCP).Aim:To assess the level of awareness, and perception of the health care providers toward GCP and subsequent change in these after a day training session on GCP guidelines.Methods: After obtaining approval from the IEC and valid informed consent, the participants were recruited into the study. A cross-sectional descriptive questionnaire-based study was conducted amongst health care providers, i.e., clinicians and ethics committee members of total 70 participants were enrolled for this one day workshop. Participants completed the questionnaire before and after undergoing a day training program in GCP guidelines. Comparison between answers in pre and post workshop questionnaire was done. The primary outcome was knowledge, which was evaluated using the paired t test.Results: In Pre workshop, out of 70, total 60 (85.7%) participants had answered all 20 questions; while 7 (10%) participants had skipped to answer one question .3 out of 70(4.3%) participants had not answered 4 to6 questions out of 20. Total 66 out of 70 (94.3%) participants in post workshop answered all questions. All 20 (100%) questions were answered correctly in post workshop as compared to 14 (70%) questions in pre workshop. So, in post-workshop, there were significant (P <0.005) gains in knowledge regarding all good clinical practice questions. Conclusion:A day's training program on GCP guidelines may help to increase the knowledge as well as awareness about principles and techniques of clinical research, which will increase the credibility of clinical research in the country.
Authors and Affiliations
Dr. N. Suresh Babu, Dr. Syamala Shanthi Kumari . B. S, Dr. Lakshmana Chintala, Dr. N. P. Sirisha
Keywords
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- EP ID EP554262
- DOI 10.9790/0853-1803036265.
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