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