: 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.

: 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.