Access To The Clinical Database

We have an externally sponsored study that is coming up to a MHRA inspection and the inspectors have requested access to the clinical database. We have tight controls over access and training is given prior to user accounts being set-up. The system we use (OpenClinica) does not have a truly ‘read-only’ role, even the monitor’s role can extract data. We have offered to have someone sit with the inspector and call up the records they want to see and/or provide full data listings however they still want access to the database.

This is something we have not come across before and would appreciate input from other CTU’s.

Have you been requested to provide access in recent inspections? Was access provided? and particularly of OpenClinica users did you assign monitor’s role?

Many thanks

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