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

: 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. : 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