Record review levels are setup by the Study Administrator based on user roles. If you have the ability to review and/or sign off on records, a button will be displayed at the bottom of every subject CRF to mark the corresponding data as reviewed at your role level (e.g. Monitor reviewed, Investigator Reviewed, etc). Bulk review functionality is also available from the Action Item Report, if the study is set up to support it.
Important points on how record review works in Clinical Studio:
- Data review workflow in Clinical Studio can be configured to allow only completed records (no open queries) to be reviewed/locked. Alternatively, studies can be set up to allow the first review level (typically Monitors) to perform initial verification regardless of the forms current state. Data changes on locked forms will break the review lock and get logged in the audit trail and Monitor Report so it is transparent to all users.
- Reviewing should not be confused with Freezing, which can be done anytime by anyone with that permission. Not all users will necessarily see the option to freeze forms.
- Studies may also be setup for partial review capabilities where a reviewer can lock individual fields on forms to prevent further data changes on specific data points. In these cases, an entire form cannot be reviewed until all necessary fields have been locked on the form. Site users may also have the permission to unlock (or unmonitor) those fields if they need to make a change. Monitored or unmonitored (locked or unlocked) fields are clearly shown in the Field Lock Report.
- For a CRF to be reviewed/locked by the first review level (typically a study Monitor), it must have no open queries or errors. The Study Administrator is who defines the level of completion that every form must have, and what defines a form as "complete."
- Once a record is reviewed/locked, no further queries can be made unless the form is unlocked. Permission to unlock forms is granted by the Study Administrator. Unlocking a form will break the review and kick at back to the first review level. Any of these actions taken on a form are displayed in the audit trail at the bottom of the CRF.
- For a list of records awaiting your review level, use the Action Item Report. The progression of records through review levels can be referenced on the Dashboard Report. For Monitors to track any initial verifications and subsequent changes that sites have made, use the Monitor Report.
Continue reading about how to open and review records.