Accounting for multiple observations per subject

[joshrapkin]

Does iMRMC account for or allow multiple observations per subject? Since the tool is already accounting for multiple readers and multiple cases, it wasn't clear to me if more than one observation per subject is allowed. If so, how do you account for this in sample size calculations and analysis?

[brandon-gallas]

The iMRMC software treats multiple observations on the same subject(s) that come from multiple readers.

The iMRMC software does not treat designs where the same reader provides multiple observations of the same case.

I will be slow to respond to future comments and issues. Our division has been impacted by the recent firings of government employees.

[brandon-gallas]

You can find all the background materials about the iMRMC methods here: https://cdrh-rst.fda.gov/imrmc-software-do-multi-reader-multi-case-statistical-analysis-reader-studies