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

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.

To strengthen the knowledge and awareness regarding GCP.

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.

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.

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.

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.

The exercise of holding training program was found to be significant in improving the knowledge base of participants, especially investigators and study coordinators.