Monitoring, Reviewing, and Signing Off On Forms
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The ability to review CRFs is set up by the Study Administrator. What is required at each review level will also vary between studies.
The example below covers record review, as it would be seen by a Monitor or similar reviewer, in a study that is set up for field source verification monitoring. Please note that your study may not contain all the functions outlined below.
When the Study Monitor logs in, all the records available for review can be found in the Action Items Report. From the Action Item Report, records can be individually selected or bulk reviewed if the study design allows for it. Alternatively, records can be accessed manually from the subject casebooks via the Subject Manager.
Here’s how to access records awaiting review from the Action Items Report:
With the applicable review level expanded within the Action Items Report, tap the ‘Go To Form’ link to open it directly. If batch process permissions have been provided, there will be checkboxes on the right side of the table, and action buttons available at the bottom.
To filter for a specific subject, visit or form, use the text search at the top of the table.
This functionality can more conveniently be accomplished on the mobile app - also from the Action Item Report or directly from subject records.
Reviewing a record where field verification is required
The example below covers record review, as it would be seen by a study Monitor, in a study that is set up with a field-level review.
Field level review is seen by the lock icons next to all or some of the fields on the form - depending on the requirements of the study. These lock icons allow the Study Administrator to require specific fields to be reviewed.
In the image below, the highlighted field has not yet been locked. Until doing so, the form as a whole cannot be marked reviewed and locked. Instead, only the specific fields are locked.
The button at the top of the page, "Lock Fields" also provides a quick option to lock all applicable fields on the page. This can be helpful when many fields exist on the page. If queries then need to be added, just tap on the needed fields to unlock those again to add queries.
The "Freeze" option at the top of the form is only to freeze the entire form in its current state and prevent further changes. This is special permission that must be granted, and is not part of the record review process.
Below is how the same record appears on a mobile device.
Queries can be accessed by tapping on the icon. The field can be locked/unlocked by a 2-second press on the same icon. The icon will also change color if queries exist on the field.
The same Lock All option exists as a quick alternative to simply locking all fields on the page. This is the lock icon at the top of the screen.
Locked fields can be unlocked and the data can be changed if the user has been granted the "Unlock Field (FLSV)" permission.
When a field(s) has been unlocked and changed, it gets recorded in the Field Lock Report along with the field verification performed by the Monitor.
Once the fields are all locked, the review button will appear at the bottom of the record as highlighted here:
This is how the same record looks on the mobile app:
After the record is reviewed, the history can be seen in the transaction audit.
Unlocking Records
By default any user role responsible for a given review level can unlock that same level if it is the most recent review level performed. Otherwise the user would need the Unlock Record permission within role security settings.
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