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Regulatory Focus™ > News Articles > India Requires Disclosure of Sponsor/Investigator Payments

India Requires Disclosure of Sponsor/Investigator Payments

Posted 05 September 2013 | By Ansis Helmanis

Applications for approval of clinical trials in India must now include information concerning the agreement as to the payments that will be made by the sponsor to the trial investigator, according to a notice issued by India's Central Drugs Standard Control Organization (CDSCO) on 30 August 2013.

India's Good Clinical Practices (GCP) regulations require the sponsor to conclude a contract with the trial investigator or institution, which must define the relationship between the parties and include the agreement as to payments such as financial support, fees, and honoraria. The contractual agreement between sponsor and investigator must be concluded before the clinical trial is initiated.

CDSCO Notice

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