Working After 1.64 Review

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 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

: 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 Impact on Clinical Professionals