Working After 1.64 【100% Tested】

: 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

: 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

Working "after" or in accordance with 1.64 and its associated sections in R3 requires a shift toward and risk-based management . : Despite the focus on flexibility, there is

: 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. This ensures clear accountability for medical decisions and

: 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.

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