ICH E6(R2) 4.2.4:“The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties.”This responsibility cannot be delegated to sponsor or IRB.
[References:ICH E6(R2), §4.2.4., ]
Contribute your Thoughts:
Chosen Answer:
This is a voting comment (?). You can switch to a simple comment. It is better to Upvote an existing comment if you don't have anything to add.
Submit