A one-day workshop on Good Clinical Practice (GCP) was held at the Return to Play Division, Indira Gandhi Stadium, New Delhi, organised by the Sports Science Division of the Sports Authority of India (SAI) in collaboration with the Indian Council of Medical Research (ICMR).
The event, conducted in a hybrid format, aimed to improve understanding of ethical and regulatory frameworks governing human studies among researchers, support staff, and key stakeholders involved in sports and clinical sports science research.
Experts from ICMR led scientific sessions covering the ICH-GCP (E6) principles, ICMR Ethical Guidelines, provisions of the National Digital Clinical Trials Registry (NDCTR) 2019, roles and responsibilities of investigators and Institutional Ethics Committees (IECs), informed consent procedures, and the management of serious adverse events (SAEs).
Dr Stuti Bhargava, Scientist-E at ICMR, highlighted the significance of GCP, stating: “Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects. It ensures the protection of participants’ rights, safety, and well-being, while guaranteeing the credibility and integrity of trial data. Compliance with these standards is essential for regulatory submissions and adherence to globally accepted guidelines.”
Brigadier (Dr) Bibhu Kalyan Nayak, Executive Director of the Sports Science Division at SAI, emphasised the importance of such capacity-building efforts. He said: “As sports science research increasingly involves advanced interventions and athlete-centric studies, adherence to Good Clinical Practice is not merely a regulatory requirement but a moral responsibility. Ensuring ethical compliance, participant safety, and data integrity is fundamental to building trust and generating credible, high-quality evidence that directly contributes to athlete performance and well-being.” He further noted that these initiatives are crucial for sensitising researchers to global best practices and strengthening India’s sports science research ecosystem.
Dr Jugal Kishore, Professor of Community Medicine at Vardhman Mahavir Medical College and Safdarjung Hospital and Chairperson of the SAI NCSSR Ethics Committee, stressed the critical role of ethics oversight in research. The workshop highlighted the increasing need to align sports research in India with internationally accepted ethical standards, reinforcing the importance of participant safety, regulatory compliance, and scientific credibility, while promoting a culture of responsible and ethical research within the sporting community.
The programme concluded with an interactive valedictory session, characterised by active participation and a collective commitment to continuous learning and enhanced clinical research governance.