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ORIGINAL ARTICLE
Year : 2019  |  Volume : 10  |  Issue : 1  |  Page : 20-25

Effect of a planned training session on good clinical practice knowledge in research professionals: A pilot study


1 Institutional Ethics Committee, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India
2 Tata Memorial Centre, Research Administrative Council, Clinical Research Secretariat, Tata Memorial Centre, Mumbai, Maharashtra, India
3 Epidemiology and Clinical Trial Unit, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India
4 Department of General Medicine, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India
5 Department of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India

Correspondence Address:
Ms. Kasturi Awatagiri
Institutional Ethics Committee, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Kharghar, Sector 22. Navi Mumbai - 410 210, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_146_17

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Context: Adherence to good clinical practice (GCP) guidelines by the researcher provides public confidence that the rights, safety and well-being of human participants involved in research are protected. It has been observed that researchers require basic GCP training. Considering this, we had decided to conduct a training session on overview of GCP. Aims: To strengthen the knowledge and awareness regarding GCP. Settings and Design: The design of the study was quasi-experimental one group, pre-test and post-test design and the study was conducted at ACTREC among healthcare professionals at Tata Memorial Centre. Methods and Material: A semi-structured questionnaire was used to collect the data in pre and post-test. A total of 138 participants were participated in the study. The training session was pre-planned which included a lecture followed by the question-answer session. Statistical Analysis Used: Wilcoxon Signed Rank test was used to assess the effect of the planned teaching programme. Macnemar test was used for item wise comparison of pre and post-test scores. Mann Whitney test was used to determine the significant difference between knowledge scores and selected demographic variables. Results: This study has resulted in overall improvement of knowledge with a median difference of 5 with P-value <0.001. There was a statistically significant improvement of knowledge between pre and post-test of those having GCP training in the past, working group and education. Conclusions: The exercise of holding training program was found to be significant in improving the knowledge base of participants, especially investigators and study coordinators.


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