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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.

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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.

Regulatory CDSCO
Phase 4 Trial (PMS)
Medical Devices

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