Working After 1.64 Apr 2026

The International Council for Harmonisation (ICH) recently updated its Good Clinical Practice (GCP) guidelines to version R3. Section 1.64 defines the , focusing on any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or make important trial-related decisions. Key Principles for Working Under R3 Standards

: 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. : The update aims to make trial processes more efficient

: 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. Working after 1.64