The World Health Organization in collaboration with the Clinical Trials Registry- India (CTRI) and the Indian Council of Medical Research (ICMR) organized the launch of ‘e-Learning Modules for Registration of Clinical Trials in India’ on 24 September 2015 in New Delhi. The e-Learning modules were launched by Dr Soumya Swaminathan, Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR). The launch was aimed at building capacity of individuals and institutions undertaking clinical research in India and sharing best practices of clinical trial registration.
Dr Soumya Swaminathan, Secretary, Department of Health Research & Director General, Indian Council of Medical Research (ICMR) stressed on the vision of the Clinical Trials Registry- India, which is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. “The e-learning modules developed by Clinical Trials Registry- India, Indian Council of Medical Research and World Health Organization will ensure efficient registration of trail data in the Clinical Trials Registry- India and thereby build the capacity of individuals or institutions undertaking clinical research in India,” she added.
The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics, is a free and online public record system for registration of clinical trials conducted in India. Clinical trial registration with CTRI was made mandatory by the Drugs Controller General (India) in 2007. Dr Zurn, Technical Officer, Health Systems Evidence and Policy, WHO mentioned that “Promoting awareness about registering the trial and updating all trial related details before the enrolment of the first patient will improve transparency, accountability and accessibility to establish public trust about clinical trials, ensure patient safety and improve patient care in the long term.”
WHO has been providing policy advice and technical support to Clinical Trials Registry- India (CTRI) from its inception in 2007, which includes ensuring its compliance with WHO International Clinical Trials Registry Platform (ICTRP).
“The e-learning modules are user-friendly training software consisting of a total of 14 modules. The modules will explain essential details to the user about how to register a clinical trial on CTRI website, explain the points to remember and describe the critical processes by which the trial data will be reviewed and approved by the scientists in CTRI. These modules would be deployed and made available free of cost to any researcher who registers on the CTRI,” highlighted Dr Arvind Pandey, Director, National Institute of Medical Statistics (NIMS), Clinical Trials Registry- India.
The launch was attended by senior officials from the Ministry of Health & Family Welfare, Department of Health Research, Department of Science and Technology, Department of Biotechnology, Central Drugs Standard Control Organization (CDSCO), Clinical Trial Registry – India (CTRI) and WHO .