CDSCO Moves Clinical Trial Site Addition, PI Change Applications to Online Platform

In a recent notice, CDSCO has mandated that applications for adding clinical trial sites and changing principal investigators must now be submitted through the SUGAM portal, an online platform designed to simplify and expedite regulatory processes.

This new system applies to various types of clinical trials, including global clinical trials, trials for new drugs, subsequent new drugs, investigational new drugs, fixed-dose combinations, and bioavailability & bioequivalence studies. The shift to an online system underscores CDSCO’s commitment to improving efficiency and transparency in clinical trial management.

"The submission of applications for addition of Clinical Trial Site and change of Principal Investigator are functional on online system of SUGAM Portal (www.cdscoonline.gov.in) for Global Clinical Trials„ Clinical trials of New Drugs, Subsequent New Drugs, investigational New Drugs, Fixed Dose Combinations and Bioavailability & Bioequivalence studies. Applicants seeking for approval of Clinical Trial Site Addition and change of Principal Investigator applications may apply through the online portal," the notice read.

Applicants are required to log in to the SUGAM portal at www.cdscoonline.gov.in and complete their submissions. Each application must include a checklist of required documents and approval from the ethics committee supervising the trial. These steps ensure that all submissions meet the necessary regulatory standards before being reviewed.

CDSCO has also introduced a timeline for automatic approvals to minimize delays. For clinical trial site additions, if no objections are raised within 30 days of application submission, the proposed site is deemed approved. Similarly, changes to the principal investigator are considered approved as soon as a complete application is received, provided all the requirements outlined in the checklist are met.

"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 30days 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 receipt of application subject to the condition that application is complete as per the checklist," the notice added.

The notice has been circulated to all relevant stakeholders through the CDSCO website and communicated to the Centre for Development of Advanced Computing (CDAC) team for effective implementation. Stakeholders are encouraged to familiarize themselves with the SUGAM portal and utilize it for future submissions.