For a ph3 study that has completed, we closed the IRT and created an archival package containing the relevant reports and data. We are now being advised that the IRT should remain open, or be recommissioned, so that it can be accessed during a future EMA inspection, particularly because the study data supports a marketing authorization submission.

For those who have been through EMA or other health authority inspections, is it standard practice for sponsors to keep the IRT system open and accessible for years after study closeout solely for potential inspection purposes?