The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff-regardless of employment source. Exact extracts:
* ICH E6(R2) 4.1.1: "The investigator should bequalified... and haveadequate resourcesto properly conduct the trial."
* ICH E6(R2) 4.1.5: "The investigatorshould ensure that all persons assistingwith the trial are adequately informedabout the protocol, the investigational product(s), and their trial-related duties and functions."
* ICH E6(R2) 4.2.5: "The investigatormay delegate... butretains responsibilityfor the conduct of the trial at the site."Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties.
References:
ICH E6(R2) Good Clinical Practice, §4.1.1; §4.1.5; §4.2.5 (Investigator responsibilities; delegation and oversight).===========