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Regulatory Focus™ > News Articles > India Proposes eSubmission Process for Clinical Trials

India Proposes eSubmission Process for Clinical Trials

Posted 30 July 2014 | By Louise Zornoza

India Proposes eSubmission Process for Clinical Trials

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India’s Central Drugs Standard Control Organization (CDSCO) has published a proposal to create an information technology (IT) system that would permit the online submission of information on clinical trials by sponsors, clinical research organizations (CROs), investigators, ethics committees and trial subjects.

Information regarding a particular clinical trial entered into the system would generate a Unique Identification Number (UIN) specific to the trial, CDSCO explained in the 28 July 2014 notice. The trial sponsor would be required to share the UIN with the trial investigators and the responsible ethics committee, and each would be required to provide information into the system on day to day basis. 

According to the CDSCO, the UIN system would enhance the ability of the agency to monitor clinical trials nationally.  The proposal is open for comments for three weeks.


CDSCO Proposal

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