After 1.64 - Working

: The update aims to make trial processes more efficient. For workers, this often translates to streamlined documentation and a focus on "quality by design" rather than just checking boxes.

: 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 1.64

Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management . : The update aims to make trial processes more efficient

: 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