84 Submission of clinical trial site addition and change of principal Investigator applications through sugam portal 2025-Feb-24 57 KB

F.No.10171/DCGI/10/2024-eoffice Government of India Directorate General of Health Service Central Drugs Standard Control Organization FDA Bhawan, Kotla Road, New Delhi-110002 2 4 FEB_ 995

Sub: Submission of Clinical Trial Site Addition and change of Principal Investigator applications through SUGAM portal -Reg.

In continuation to notice vide F.No.1017/DCG(I)/10/2024-eoffice dated 26.12.2024 on the subject sited above, the submission of applications for addition of Clinical _ Trial Site and change of Principal Investigator are now also functional on online — system of SUGAM Portal (www.cdsconline.gov.in) for clinical trials of Biological products (Vaccine and rDNA). Applicants seeking for approval of Clinical Trial Site Addition and change of Principal Investigator applications for all the clinical trials may apply through the online portal.

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 clinical trial sites is deemed to be approved if no objection Is received from the CDSCO within 30days of the receipt of the application and the proposed change of Principal Investigator is deemed to be approved by the CDSCO from date of receipt of application subject to the condition that application is complete as per the checklist

r.Raj iAigh\Raghuvanshi) Drugs Controller General(India)

To,

1.All stakeholders through CDSCO website

2.CDAC team

1

tile No. DCG1/10/2024-eoffice (Computer No. 10171)