Working After 1.64 May 2026

: Despite the focus on flexibility, there is a continued emphasis on maintaining reliable, trustworthy data. Workers must ensure that all sub-investigator qualifications and delegated tasks are accurately recorded in the Delegation of Authority Log . GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) - ICH

Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management . Working after 1.64

: 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. : Despite the focus on flexibility, there is