The applications for addition of Clinical Trial Site and change of Principal Investigator for all clinical trials including clinical trials of Biological products (Vaccine and rDNA) are now applied through SUGAM Portal (www.cdsconline.gov.in). 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.
The said notice is in continuation to notice vide F.No.1017/DCG(I)/10/2024-eoffice dated 26.12.2024. The applications for addition of Clinical Trial Site and change of Principal Investigator for clinical trials of Biological products (Vaccine and rDNA) are now functional on online system of SUGAM Portal (www.cdsconline.gov.in). Earlier the Portal was funtional only for Clinical Trials of Drugs, FDCs and for Bioavailability and Bioequivalence Studies.
Hence, the Applicants seeking for approval of Clinical Trial Site Addition and change of Principal Investigator applications for all the clinical trials now required to apply through the online portal along with the checklist of documents and 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.
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