Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
CT Rules.pptx
1. In accordance with the 2019-CTRules, the Hdbk-ClinTrial, the G-ICMR, and IND-31, India requires the sponsor (applicant) to obtain
clinical trial authorization from the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization
(CDSCO), and the investigator to obtain ethics committee (EC) approval from a DCGI-registered EC prior to initiating a study. In
addition, according to IND-31 and IND-13, the DCGI review and approval process may be conducted in parallel with the EC review for
each clinical trial site. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules.)