The Central Drugs Standard Control Organization (CDSCO) on December 26, 2024, issued the notification regarding the Submission of clinical trial site addition and change of principal investigator applications through Sugam Portal.
The following has been stated namely: -
• The submission of applications for addition of Clinical Trial Site and change of Principal Investigator are functional on online system of SUGAM Portal for Global Clinical Trials, Clinical trials of New Drugs, Subsequent New Drugs, Investigational new Drugs, Fixed Dose Combinations and Bioavailability and Bioequivalence studies.
• The applicant should submit application through SUGAM along with the checklist of documents along with the approval of the ethics committee.
• The proposed addition of the clinical trial sites is deemed to be approved if no objection is received from the CDSCO within 30 days of the receipt of the application and the proposed change of Principal Investigator is deemed to be approved by the CDSCO from the date of receipts of application subject to the condition that application is complete as per the checklist.
[Notification No. 10171/DCGI/10/2024-eoffice]
