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Submission of clinical trial site addition and change of Principal Investigator applications through SUGAM portal

News Healthcare & Pharma English General Updates
Date: 26th Dec, 2024 Source: Central Drugs Standard Control Organization (CDSCO) Country: India Original Source

Brief

The Central Drugs Standard Control Organization (CDSCO) has streamlined the regulatory submission process by enabling applications for adding clinical trial sites and changing principal investigators through the SUGAM online portal. If no objections are raised within 30 days, the site addition is deemed approved, while principal investigator changes are approved upon receipt of a complete application.

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Central Drugs Standard Control Organization (CDSCO)

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