Working After 1.64 May 2026

: 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

: 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

: 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

Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management . Working "after" or in accordance with 1