Published on: March 26, 2025
The Department of Clinical Research at the Himalayan Institute of Medical Sciences (HIMS), Swami Rama Himalayan University, organized a workshop on Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Ethics on 26th March 2025. Held at Sushruta LT-3, the workshop aimed to deepen the understanding of regulatory guidelines, ethical considerations, and best practices essential for clinical and laboratory research among 117 postgraduate students and faculty members.
The event began with a pretest to assess participants’ baseline knowledge of GCP, GLP, and research ethics. The sessions covered a comprehensive range of topics, starting with new drug discovery and development, presented by Dr. Nikku Yadav, which outlined the stages from preclinical testing to post-market surveillance. Prof. A.K. Srivastava explained various epidemiological study designs, distinguishing between observational and experimental studies, and highlighting their appropriate use in research.
Dr. Taruna Sharma discussed the fundamental principles of GCP, emphasizing its critical role in clinical research to ensure participant safety and study integrity. Mr. Abhinav Bahuguna introduced the basics of biostatistics, including study design, data types, and the importance of minimizing bias and error. The workshop also addressed professional ethics, where Dr. Pragya Tripathi elaborated on the medical code of conduct, underscoring patient welfare, competence, integrity, and accountability.
A key session on human research ethics was conducted by Prof. D.C. Dhasmana, focusing on the New Drugs and Clinical Trials Rules (NDCT) 2019. This included the responsibilities of sponsors, investigators, and Institutional Ethics Committees, as well as the informed consent process designed to protect research participants, especially vulnerable groups. Dr. Manisha Sharma highlighted Indian GCP and GLP guidelines, stressing ethical conduct, scientific rigor, data confidentiality, quality assurance, and regulatory compliance in clinical trials and laboratory studies.
To reinforce learning, MSc Clinical Research students performed role plays simulating study start-up activities, providing practical insights into regulatory trial procedures. The workshop concluded with an interactive post-test and feedback session, confirming enhanced participant knowledge and appreciation of the ethical and regulatory frameworks governing clinical research.
Overall, the workshop successfully fostered awareness and adherence to good practices and ethical standards necessary for quality biomedical research. It was recommended that continuous educational initiatives be implemented to further strengthen regulatory compliance and promote interdisciplinary collaboration among researchers and healthcare professionals.
