: Following 1.64 ensures that the work performed at a local site is recognized and accepted by regulatory authorities worldwide, such as the US FDA or EMA.
Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management .
: Every person working as a sub-investigator must be explicitly designated. This ensures clear accountability for medical decisions and data integrity.
: Following 1.64 ensures that the work performed at a local site is recognized and accepted by regulatory authorities worldwide, such as the US FDA or EMA.
Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management .
: Every person working as a sub-investigator must be explicitly designated. This ensures clear accountability for medical decisions and data integrity.