Online submission of SAE reports through SUGAM portal

Online submission of SAE reports through SUGAM portal


The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of clinical trial applications. Electronic submissions make the submission process hassle-free. It also enables the easy tracking of applications. The latest development in the space of e-governance is the launch of a software for the online submission of SAE reports. On February 25, 2021, CDSCO released a notice requesting all stakeholders involved in clinical trials for the online submission of SAE reports through the SUGAM portal (www.cdscoonline.gov.in) from March 14, 2021. CDSCO will not accept physical/offline files of SAE reports for processing from March 14, 2021. The online submission of SAE reports is expected to reduce the time and transaction cost. To enable a smooth transition to the online platform, CDSCO has developed a user manual and video tutorial, which is now available on the CDSCO website. To report SAE on the SUGAM portal, the sponsor will have to follow a set of steps to fill up the database and for proper linking of data. All steps have been explained in the user manual with the help of screenshots for ease of understanding. It should be noted that the follow-up reports of SAE reports which are already submitted can be continued to be submitted in offline mode.

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