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Those massive reports we sometimes see at continuing review? You don’t have read the whole thing.

It’s not unusual for sponsors of multisite studies to draft long, periodic reports summarizing overall study progress. We recently saw one in the IRB that was more than 160 pages long submitted with a continuing review (CR). Please note that if you see one of these in a CR you are reviewing, you are NOT expected to read the entire document front to back. Instead, scan it to see if you can find a summary describing a change in risk or any other significant changes noted in the sponsor’s review. These reports are often routine summations of study activity over all sites over the previous review period and they may have no direct impact on local site activities.