After 1.64 — Working

: The principal investigator (PI) maintains ultimate responsibility. Working under 1.64 requires documented evidence that the PI is supervising sub-investigators, particularly when they are performing tasks like participant screening or safety assessments.

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

: 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 1.64

: Every person working as a sub-investigator must be explicitly designated. This ensures clear accountability for medical decisions and data integrity. Working after 1.64