The New Drugs and Clinical Trials rules 2019 needs that all the investigator, sponsored/CT-NOC holders, and the ethics committee should report all the SAE or Serious Adverse Events to the Central Licensing Authority at a specific time period.

CDSCO initiated making electronic submissions of all clinical trial applications with the help of the SUGAM portal. With electronic submission, the whole process of submissions becomes flawless and without any hassles. Not only that, but also it assists in tracking the applications very easily.

In e-governance, one of the recent developments is the software launch for online submission of SAE reports. On February 25, 2021, CDSCO gave a notice, thereby directing all the stakeholders involved in clinical trials for submitting the SAE reports through the SUGAM portal starting from March 14, 2021. Henceforth, CDSCO will not accept any physical or offline files of the SAE reports for handling from the date March 14, 2021.

Because of the online submission of all SAE reports, there will be a huge reduction in both times and cost of the transaction. For making an easy-shifting from the physical submission of reports to an online platform, CDSCO has created a user manual as well as a video tutorial that is available on the CDSCO website.

For reporting SAE reports in the SUGAM portal, the sponsorer will follow some steps to fill all the database and perfect data linking. The steps involved are clearly explained in the user manual present on the CDSCO website. To facilitate easy understanding, there are screenshots of all steps.

But it has also been notified that all the follow-up reports of the SAE report that have already been submitted can be submitted in offline mode.

The whole process of online submission helps speed up the whole process and assists in meeting the respective timelines for reporting SAE. It will also prevent situations where a courier of SAE report submission by an ethics committee or by the site is not received by CDSCO, thereby avoiding the hassles of re-submission of reports.

Furthermore, as the reported SAE from a trial is linked with the sponsor, ethics committee, and investigator of the site, this process of e-submission helps avoid duplication of all information that is offered by all.

Initially, you might feel like you have to give more detailed information while reporting SAE, therefore the follow up reporting for the same case only the upgraded information is required.

The whole process of e-submission of the clinical trial application in the SUGAM portal has assisted in making the process easy.

Thus, e-submission of SAE is considered a major part of the evolution of several e-submission to CDSCO. It reduces the total timelines and assists in rapid conductance of clinical trials and increases efficiencies.

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