Question

In india adverse effects in clinical trials reported to

Answer 1

Answer:

management of the AE/ADR rests on the investigator. According to the DCR-6th Amdmt,[3] the investigator should report all SAEs to the drug regulatory body of India (DCGI), sponsor of the trial, and the concerned EC that approved the trial protocol within 24 h of occurrence of the SAE.

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Answer 2

management of the AE/ADR rests on the investigator. According to the DCR-6th Amdmt,[3] the investigator should report all SAEs to the drug regulatory body of India (DCGI), sponsor of the trial, and the concerned EC that approved the trial protocol within 24 h of occurrence of the SAE.