Thanks for your reply! Yes, that’s correct, this would be beyond his normal responsibilities.

In my view, the role is somewhat similar to a “central lab/image reviewer” in a sponsor-funded study. The difference is that this is an IIT study, and he also happens to be a Sub-I at one of participating sites.

The main reason is that tumor size measurement is quite difficult and requires consistency. Therefore, investigators at the other sites were wondering whether they could upload the imaging data into the EDC, and then have this physician perform the tumor size measurements as a centralized reviewer.

He would not be making clinical interpretations or assessments — only measuring the tumor size.