Abstract

Background: Good Clinical Practice (GCP) is an international quality standard for conducting trials that involve participation of human subjects. Good Clinical Practice guidelines are provide the human rights protection, assurance of the safety and well being of subject participating in clinical trials of the newly developed compound. The objective of this study was to show the effectiveness of workshop training in basic principles of Good Clinical Practice among the Medical teachers of Government Medical College, Bhavnagar and will learn the practical application of GCP regulations for critical components of the clinical research Process.
Objective: The main objective of this study was to show the effectiveness of workshop training in basic principles of Good Clinical Practice among the Medical teachers Methods: A total 125 medical teachers of Government Medical College attached with Sir Takhtsinhji Hospital, a tertiary care hospital, Bhavnagar, Gujarat professionals were participated in Good Clinical Practice training workshop. The study was included total twenty questioners based on the most widely accepted international document forming the base for ICH Harmonised Tripartite Guideline for GCP (ICH-GCP E6), which defines in detail the responsibilities and obligations of parties engaged in clinical research. They were submitted given questioners with answers before and after the workshop training. The data was Mean and SD calculated using SPSS software.
Results: The total twenty questions were analyzed and compare with the standard key of this. Pre training test score of Question no. 2, 5, 7, 16 was 19(15%), 35 (28%), 21 (17%), 14 (11%) and post training score was 70(88%), 95(76%), 64(51%), 75(60%) respectively. This number as well as percentage could show more improvement in knowledge regarding basic principle of Good Clinical Practice. In our study results shown that there was improve overall knowledge after the given Good Clinical practice training. Conclusion - Training workshop with interactive sessions among the participants after some lectures followed by Multiple Choice Questions test not only improved but also update the participations knowledge regarding subject