Shubhasis Dan, Sanmay Karmakar, Balaram Ghosh and Tapan Kumar Pal
Supervision provides a foundation for future workers to learn practical skills from a qualified professional, and is essential for the development of a profession. Supervision is also very much essential for developing workforces. Recently CDSCO has proposed to create an IT enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining comprehensive database and monitoring The clinical trials for ensuring the protection of rights, safety and well beings of trial subjects and authenticity of the data generated. Looking at the current regulatory environment of clinical trial in India, it is very much important to collate all the information related to four major domains of clinical trial to bioequivalence study captured online in an organized manner. These domains are: Sponsor/ CRO, Investigator, Ethics Committee (EC) and Patient/ volunteer. In order to get access to all the information, all the sponsors/CROs, Investigators and Ethics Committees are required to put the information in a common repository related to a particular CT which will be updated by the stakeholders on day to day basis.
The efforts of the Indian Regulators towards ensuring the patient safety and data credibility are discussed in the present study.
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