Working After 1.64 -

: 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

: 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.

: 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 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

: 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

: 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.

: Every person working as a sub-investigator must be explicitly designated. This ensures clear accountability for medical decisions and data integrity. GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) - ICH

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