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Perspect Clin Res. 2019 Jan-Mar;10(1):20-25. doi: 10.4103/picr.PICR_146_17.

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

Author information

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.

Abstract

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.

KEYWORDS:

Advanced Centre for Training; Research and Education in Cancer; good clinical practice; health professional; pre- and post-design

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