alexa Digitization of Clinical Trials in India: A New Step by CDSCO towards Ensuring the Data Credibility and Patient Safety
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

Digitization of Clinical Trials in India: A New Step by CDSCO towards Ensuring the Data Credibility and Patient Safety

Shubhasis Dan1, Sanmay Karmakar1, Balaram Ghosh2 and Tapan Kumar Pal1*

1Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal

2Midnapore Medical College, Govt. of West Bengal, Medinipore, West Bengal

*Corresponding Author:
Tapan Kumar Pal
Emeritus Medical Scientist (ICMR) and Ex-Director
Bioequivalence Study Centre
Department of Pharmaceutical Technology
Jadavpur University, Kolkata -700 032, India
Tel: +91-9830036297
E-mail: [email protected]

Received date: July 20, 2015; Accepted date: August 13, 2015; Published date: August 17, 2015

Citation: Dan S, Karmakar S, Ghosh B, Pal TK (2015) Digitization of Clinical Trials in India: A New Step by CDSCO towards Ensuring the Data Credibility and Patient Safety. Pharmaceut Reg Affairs 4:149. doi:10.4172/2167-7689.1000149

Copyright: © 2015 Pal TK, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

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 trialsto 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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