Research Journal of Medical Sciences
ISSN: Online 1993-6095ISSN: Print 1815-9346
Abstract
Documentation is an integral component of clinical research. This study assessed the knowledge of Pharma D pharmacology students towards good documentation practices (GDP) in clinical trials by comparing the results of pre‐and post‐workshop. A structured questionnaire comprising 15 questions on GDP was developed by the research team and validated by experts. This questionnaire (pre‐and post‐workshop surveys) was created using Google Forms and consisted of multiple question types. The link to the survey was then sent via email to all participating students before and after the workshop. The results were compared and presented as percentages. A total of 35 pharmacology students participated in the pre‐workshop survey, of which only 20 completed the post‐workshop questionnaire survey. Of the students, 77.1% were familiar with the complete ICH‐GCP, but this number decreased to 50% following the post‐workshop survey. An increase in the students’ knowledge of the approval board was observed following the post‐workshop survey (20%). The workshop's outcomes enhanced the students' understanding of the pediatric eligibility age for clinical trials, boosting their knowledge from 60‐85%. In the post‐workshop survey, a larger percentage of students were able to provide correct answers. The majority of the participants were successful in identifying that the consent form would be obtained from legally authorized representatives, as indicated by the pre‐workshop survey, which showed 97.1% correct responses and the post‐workshop survey, which reported 100% accuracy. In the pre‐workshop survey, 80% of the participants answered correctly, whereas after the workshop, this figure increased to 90% in relation to site monitoring visits. This study demonstrated positive outcomes in terms of increasing students’ knowledge of good documentation practices in clinical trials. It is essential to devote additional effort to enhancing documentation practices by offering structured training and workshops on documentation standards to all pharmacology students, fostering positive attitudes and inspiring them to create a culture of information.
How to cite this article:
L.J. Kiran, K.G. Shivashankaramurthy, M. Naveen Kumar and N. Lavanya. Assessment of Knowledge Towards Good Documentation Practices Among Pharm D Pharmacology Students.
DOI: https://doi.org/10.36478/10.36478/makrjms.2024.11.178.182
URL: https://www.makhillpublications.co/view-article/1815-9346/10.36478/makrjms.2024.11.178.182