The Indian Society for Clinical Research (ISCR) has welcomed online submission of serious adverse events (SAEs) arising from clinical trials in the country through SUGAM portal saying that it will speed up processes and help meet the regulatory timelines for reporting SAEs.
It will also help in easy traceability of the SAEs and will avoid a situation in which a courier of SAE report submission by the site or Sponsor or an Ethics Committee isn’t received by the Central Drugs Standard Control Organization (CDSCO), thus avoiding its re-submission, says Dr Chirag Trivedi, president, ISCR.
The CDSCO has come out with a training module which will help in the process of this e-submission, he said.
Since a reported SAE from a trial will be linked with its Sponsor, Investigator and the Ethics Committee of that site, this e-submission will avoid duplication of the information provided by all three, stated Dr Trivedi.
Though initially, it may feel like the site may have to enter more details when reporting the SAE for the first time, it may be so that for any subsequent follow-up reporting for the same case, only the updated information will have to be provided, said ISCR president.
Since some years, CDSCO has started the process of e-submissions of clinical trial applications in its SUGAM portal. This process has helped to ease the submission process and to easily trace and track the applications. E-submission of SAEs is thus a part of the evolution of various e-submissions to the CDSCO.
Replying to a query on advantages that the online process brings in the clinical trial sector in India, Dr Tivedi said “Online submission does lead to a decrease in the overall timelines and thus helps in faster conduct of the clinical trial and enhances efficiencies."
The CDSCO on February 25, 2021 issued a notification asking all stakeholders involved in clinical trials for online submission of SAE reports through SUGAM portal (www.cdscoonline.gov.in) from March 14, 2021 to reduce time and transaction cost. It will not accept physical/offline files of SAE reports for processing from March 14, 2021.
However, follow up reports of the already submitted SAE reports shall be continued to be submitted in offline mode.
|