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ICT DDR: IND Protocol Amendments Guidance and Template for Drug ProductsVersion 1.0IND Protocol Amendments: IND Protocol Amendments Guidance and Template for Drug ProductsICTR Navigators July 23,
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The ICRT DDRS IND protocol refers to the protocol for Investigational New Drug applications submitted via the Electronic Industry-wide Data Exchange.
All pharmaceutical companies and research institutions conducting clinical trials are required to file the ICRT DDRS IND protocol.
The ICRT DDRS IND protocol can be filled out electronically through the Electronic Industry-wide Data Exchange platform.
The purpose of the ICRT DDRS IND protocol is to provide a standardized format for submitting Investigational New Drug applications.
The ICRT DDRS IND protocol requires reporting of detailed information about the investigational drug, study design, objectives, and safety data.
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