Impact of educational intervention on knowledge and awareness of good clinical practice among healthcare professionals at a tertiary care teaching hospital
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Background: Good clinical practice (GCP) ensures ethical, as well as scientific quality of clinical trials, thus safeguarding participant safety and data integrity. The drug controller general of India mandates GCP training for healthcare professionals who conduct clinical research. However, limited studies assess the effectiveness of such training programs in India. Aim: This study evaluates the impact of educational intervention on the knowledge and awareness of GCP among healthcare professionals. Settings and Design: A prospective, interventional study was conducted at our tertiary care teaching hospital. Materials and Methods: A total of 180 healthcare professionals participated in a GCP workshop, with 172 completing pre- and post-intervention questionnaires. The workshop covered essential GCP topics, including ethical guidelines, informed consent, regulatory requirements, and serious adverse event reporting. Statistical Analysis Used: < 0.05 was considered statistically significant. Results: The study revealed a significant improvement in participants' knowledge across multiple GCP domains. However, gaps remained in understanding specific regulatory timelines. Conclusion: Educational interventions, such as GCP workshops, significantly enhance healthcare professionals' knowledge and awareness, improving compliance with ethical and regulatory requirements in clinical research. Integrating GCP training into medical education may further strengthen research practices.
Authors: Mrunalini V. Kalikar, Pradipta A. Dutta, Shubham S. Nimbhorkar
Institution: Government Medical College
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4414567633