SubI as central tumor size measurement role for multiple sites
Hi,
I’d like to seek your comments :)
For an local IIT study, there is a Sub-I at Site A who is responsible for tumor size measurement.
Would it be acceptable for the same Sub-I to also perform centralized tumor size measurements for Sites B, C, and D?
I think this physician would not serve as a Sub-I for other study sites. Instead, personnel at Sites B, C, and D will upload the imaging files to the CRF/EDC, and the physician at Site A would perform centralized tumor size measurements as the central reviewer for this study.
Would this arrangement be considered acceptable and reasonable?
If this role is defined as a “central reviewer,” would this arrangement need to be notified to / approved by the IRB? ( I think no need)
In addition, would a separate contract? (I think it is required for paying the review fee for this Sub-I)
Any comment is appreciated! Thank you.