Abstract

Good Clinical Practice (GCP) in clinical research is important for protecting the participants of a clinical trial. Sound knowledge of GCP is essential for conducting clinical research. Keeping the interest of patients participating in clinical research in mind, the GCP workshop was conducted in Malda Medical College. A questionnaire survey, pre-test was conducted to assess the level of knowledge of the participants before GCP workshop. After the GCP workshop again, a questionnaire survey post-test was conducted. Oral informed consent was obtained from each participant after informing them about the purpose of the study as well as the risks, benefit and rights of the study participants. Wilcoxon Signed Rank test was used for calculation. The pre-test and post-test GCP score of the participants in the following questions was statistically significant. First question “Waiver in informed consent may be justified when” 15 participants answered correctly in pre-GCP set up, in post GCP, 27 participants answered correctly. Second question “You enroll someone in study during hospitalization. The subject develops hospital acquired pneumonia and has to stay extra 2 days in hospital. How is pneumonia reported?”, in pre-GCP set-up 20 participants answered correctly whereas in post-GCP 29 participants answered correctly. GCP workshop was instrumental in increasing the awareness of participant about the fundamentals of clinical research. This workshop was able to increase the knowledge of the participants significantly (

Key words: GCP, Participants, Research, Sensitize