Clinical Trial Site Addition and Principal Investigator Change via SUGAM Portal

Clinical Trial Site Addition and Principal Investigator Change via SUGAM Portal

The Directorate General of Health Services has announced that applications for Clinical Trial Site Addition and change of Principal Investigator can now be submitted online via the SUGAM Portal. Applications will be deemed approved if no objections are raised by CDSCO within 30 days and the application is complete.

The Central Drugs Standard Control Organization has made it easier to submit applications for Clinical Trial Site Addition and change of Principal Investigator. Key points include:

• Applicants must submit their applications via SUGAM, including a checklist of documents and ethics committee approval.
• The proposed addition of clinical trial sites will be deemed approved if CDSCO does not object within 30 days.
• The change of Principal Investigator will be approved upon receipt of the complete application, subject to the checklist requirements.

These applications can be submitted through the online SUGAM Portal (www.cdscoonline.gov.in), covering Global Clinical Trials, New Drugs, Investigational New Drugs, Fixed Dose Combinations, and Bioavailability & Bioequivalence studies.