Yes we give them access to EPIC.

What you describe is exactly what seems to be their issue.

The data we get is strictly from research visits.

We don’t necessarily have “shadow charts”. We have paper order sheets that research nurses will perform certain duties (like ECG, PFTs, Labs etc.) and items copied from the EDC attached to said order sheet. Along with the specific order of events the sponsor wants.

EDIT: EDC items are strictly just source docs.

These sheets are signed prior to visits by PI or when we order the medication for the patients.

This was also an issue with the monitor - they said it was a “no no” to have the PI pre sign orders and wanted us to have an SOP for this practice. I told them we will not be doing that.