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

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.