The 'Monitoring' module allows monitors to create data queries for fields in a study. These data queries or queries are issues the monitor has identified with the value entered in a field. Queries need to be closed for a record to be marked as complete.
This module is only available for studies that are using the additional Monitoring package. When the Monitoring module is enabled in a study, administrators can review all open and closed queries on the monitoring tab. Users with only data-entry rights can see all queries for a record within the record (data-entry), on the record's 'Monitoring' tab.
To enable monitoring in your Study, navigate to the 'Settings' tab. In the 'Study' sub-tab, use the drop-down menu and set Monitoring to "Yes". Make sure to save the changes you have made by clicking the 'Save Changes' button:
Add data queries to a field
Data queries can only be created by users with the 'Query' right (monitors). To create a query for a field, enter the data entry view and click on the cogwheel next to the field you wish to add a query for. Choose 'Queries' from the presented options:
The query window
When creating a new query, the query window will have the following items:
- The current query status.
- Remarks (empty for a new query).
- The new remark field, this is where you enter a remark that you have for this field.
- The 'Update' button, this saves the query and closes the query window.
- Start by adding some text to the remark window, and clicking "Update".
You will now see the field status has been updated to "required/unfinished" and query icon (question mark) has appeared:
There are three types of query icons: New (this means: open/unconfirmed/confirmed). Resolved and Closed:
This query icon also appears on the record list in the Query column, so any researcher (non monitor) can see there is an issue with the record:
The icon that is displayed on the record list will always be the status that has the most importance. In order of importance, the queries are as follows:
Therefore, even if there is only one data query in the record with the status "New", the record list will always show the icon that indicates there is a new query. The "New" query status indicates a newly added query by a monitor that has not been (un)confirmed/resolved by a user.
Viewing and answering queries for a single record
Now that a query has appeared on the record list, a researcher (usually the person who added the record/patient) should resolve it. To answer/resolve a query, open the record and click on the 'Monitoring' tab. The monitoring tab (inside a record) shows all queries that are present for the current record:
Queries can be filtered by status. Remarks in queries are viewed by clicking on the status icon. Clicking on the arrow icon will directly open to the step in the form that the field is on.
Updating the query status
When an existing query is opened, the status is set as New. A normal user can either set the status to:
- Open: The user has acknowledged/opened the query, and added a remark. The status changes from New to Open.
- Unconfirmed: The user does not agree with the monitor.
- Confirmed: The user agrees with the monitor and will try to resolve the issue.
- Resolved: The user has changed the value and indicates the issue is resolved, for example the user has reacted to a query and left a comment. In this case the query is not closed which why the step status is shown as amber, and not green - the query is still open.
- [Only with 'Query' right (monitor)] Closed: The monitor indicates the issue is resolved and marks the query as closed. The query icon will turn into a green check mark and the progress button of the entire step will be green indicating that the step has been completed - all data entered and there are no open queries.
The status can only be changed when accompanied by a remark.
To update the status of a query, please choose the appropriate status from the drop-down, enter your remark, and press the 'Update' button.
The monitoring panel in management
Users with the "Manage Record" right can also access the 'Monitoring' tab in the study:
There are two differences in this overview, when compared to the query overview in a single record. The record IDs are listed - only records which have queries attached to them are shown. There is no 'View' (eye) icon beside each record, however it is still possible to open the query window and update the query by clicking on the status icon.
It is also possible to see per phase/step if there are any comments, how many open queries there are and if the phase/step is SDV’ed, signed, or locked in the records overview in view mode Lists.