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Event Report: Training Workshop on Good Clinical Practice (GCP) and Ethics in Clinical Research

On the 19th of February 2025, the Academy for Applied Research and Training in Healthcare in India (AARTH-INDIA) successfully conducted a one-day "Training Workshop on Good Clinical Practice (GCP) and Ethics in Clinical Research" at Raghunath Ayurved Mahavidyalaya, Contai. The event aimed to enhance the knowledge and competencies of faculty members regarding ethical considerations and regulatory standards in clinical research.

Workshop Overview

The session, led by the esteemed resource faculty, Dr. Santanu K Tripathi (MBBS, MD, DM), provided a comprehensive understanding of the fundamentals of Good Clinical Practice (GCP) and its application in clinical research, particularly in the context of Ayurveda. The workshop emphasized the importance of ethical conduct, scientific rigor, and regulatory compliance in investigator-initiated clinical research.

Program Highlights

The workshop covered the following key sub-themes:

• Introduction to Clinical Research: Exploring the purpose, types, and methodologies in clinical research.
• Evolution and Principles of GCP: Tracing the development of GCP guidelines and their significance in ensuring ethical research.
• Ayurveda and Evidence Generation: Addressing the need for robust scientific evidence in contemporary Ayurvedic practice.
• CCRAS Clinical Evaluation Guidelines 2018: Understanding the framework for evaluating Ayurvedic treatments.
• ICMR Ethics Guidelines 2017: Reviewing ethical considerations in biomedical and health research.
• Roles and Responsibilities of Stakeholders: Examining the obligations of investigators, ethics committees, and regulatory bodies.
• Institutional Ethics Committee (IEC) SOPs: Understanding the standard operating procedures for ethics review.
• Informed Consent Process: Exploring ethical challenges and best practices in obtaining informed consent.
• Challenges in Academic Investigator-Initiated Clinical Research: Identifying barriers and proposing solutions for ethical and regulatory compliance.

Interactive Assessments and Discussions

To assess participants’ learning, pre- and post-assessments were conducted, measuring their understanding of the key topics. Faculty members actively engaged in discussions, sharing their experiences and concerns regarding clinical research in Ayurveda. The interactive nature of the workshop facilitated a collaborative learning environment.

Conclusion

The workshop was well-received by the faculty members of Raghunath Ayurved Mahavidyalaya, Contai, who appreciated the depth of knowledge imparted and the practical insights shared. The event underscored the importance of ethical considerations in clinical research and reinforced the need for adherence to GCP standards in Ayurveda-based investigations.

Moving forward, such initiatives will continue to play a crucial role in enhancing research quality and ethical compliance in Ayurveda and allied health sciences. AARTH-INDIA remains committed to supporting academic institutions in fostering a robust research culture through training and capacity-building programs.