Working After 1.64 ✮ < Authentic >

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

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

: 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. : Every person working as a sub-investigator must

: 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

: 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

: 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.

: Version R3 introduces more flexibility for using digital tools. Working after these updates means clinical staff must be proficient in decentralized trial technologies and electronic data capture (EDC) systems, as the guideline now better supports their use. Impact on Clinical Professionals