Create manual query
While working with case report forms (CRFs) in EDC and finding some inaccurate or missing data, you can create queries for the accountable users to address the issues and either correct them or confirm the data's accuracy. A query is a request to fix the encountered discrepancy in the study data.
Manual queries are created by users when some data is missing, questionable, or does not match the expected criteria.
In DATA ENTRY, you can create the required manual query at the visit level, form level, item level, and record level.
At times, certain missing or incorrect information from a particular visit might need to be resolved. To resolve such a concern, it is significant to create a manual query for the specific visit so that the accountable users can resolve the issue. You can create multiple queries for a certain visit if required.
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In the EDC application header, select the DATA ENTRY tab.
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On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Viewing site tile
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In the Subject ID column, next to the needed subject, select the link representing the subject data for which you want to create a manual query.
Figure 2. Locating your subject
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On the Subject Visit Overview page that appears, under the Action column next to the needed visit, select Open Query
.
Figure 3. Location option to open query
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In the Manual Query dialog that appears, provide the details as explained in the following table.
Figure 4. Entering manual query details
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Topic*
Enter the issue on which you are creating the query: point out data discrepancies, ask a question of an addressee, provide the correct data to be updated, or else.
Expected Days*
Enter the number of days for an assignee to resolve the query before it becomes overdue. If the query is not addressed before the window of days established for resolving it has been exceeded, the query icon changes to Overdue Open Manual Query
.Assigned To*
Expand the dropdown menu to select the user role that you want to address the query. Be very careful when specifying the assignee because only the users of the selected role can view the query in their tasks. Assigning the query to the wrong user role can cause a serious delay or even prevent it from resolution.
The list of available user roles for this field is study-specific and depends on settings made in the ADMIN application.
SAVE
Select
to confirm the query creation.CANCEL
Select
to dismiss all the implemented changes without saving and close the dialog.
Upon saving, your manual query is open, and Open Manual Query 
appears next to the visit. The assignees can review and resolve it on their side.
Case report forms (CRFs) are a mechanism that you use to collect study data. In the form, if particular information is missing or incorrect, you can create a manual query for the entire form. Once the manual query is created, the accountable team members can preview and resolve the query. You can create multiple queries for one form.
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In the EDC application header, select the DATA ENTRY tab.
-
On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Viewing site tile
-
In the Subject ID column, next to the needed subject, select the link representing the subject data for which you want to create a manual query.
Figure 2. Locating your subject
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On the Subject Visit Overview page that opens, on the left a panel with all subject visits is displayed. Expand the needed visit, and in the resulting list, locate and select the form of your interest.
Figure 3. Left panel. Visits and their forms
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On the form page that appears, from the workspace toolbar, select Open Query
.
Figure 4. Selecting option to open query
-
In the Manual Query dialog that opens, fill in the fields as explained in the following table.
Figure 5. Adding manual query details
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Topic*
Enter the issue on which you are creating the query: point out data discrepancies, ask a question of an addressee, provide the correct data to be updated, or else.
Expected Days*
Enter the number of days for an assignee to resolve the query before it becomes overdue.
If the query is not addressed before the window of days established for resolving it has been exceeded, the query icon changes to Overdue Open Manual Query
.Assigned to*
Expand the dropdown menu to select the user role that you want to address the query. Be very careful when specifying the assignee because only the users of the selected role can view the query in their tasks. Assigning the query to the wrong user role can cause a serious delay or even prevent it from resolution.
The list of available user roles for this field is study-specific and depends on settings made in the ADMIN application.
SAVE
Select
to confirm the query creation.CANCEL
Select
to dismiss all the implemented changes without saving and close the dialog.
Upon saving, your manual query is open and Open Manual Query appears next to the form. The assignees can review and resolve it on their side.
Case report forms (CRFs) are a mechanism that you use to collect study data. These forms contain different variables or fields. You can create a manual query for an individual record of a form when some data is missing, questionable, or does not match the expected criteria. Once the query is created, the responsible team members can preview and resolve the query.
-
In the EDC application header, select the DATA ENTRY tab.
-
On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Viewing site tile
-
In the Subject ID column, next to the needed subject, select the link representing the subject data for which you want to create a manual query.
Figure 2. Locating your subject
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On the Subject Visit Overview page that opens, on the left a panel with all subject visits is displayed. Expand the needed visit and in the resulting list, locate and select the simple, grid, or log form.
Figure 3. Left panel. Visits and their forms
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For simple form: on the simple form page that appears, next to the needed record, select gear icon
, and in the resulting menu, select Open Query .
Figure 4. Locating manual query
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For the grid form: on the grid form page that appears, next to the needed record, select more actions menu
, and in the resulting menu select Open Query .
Figure 5. Locating manual query
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For the log form: on the log form page that appears, next to the needed record, under the Actions column, select Open Query
.
Figure 6. Locating manual query
-
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In the Manual Query dialog that appears, fill in the fields as explained in the following table.
Figure 7. Entering manual query details
Element
Details
Topic*
Enter the issue on which you are creating the query: point out data discrepancies, ask a question of an addressee, provide the correct data to be updated, or else.
Expected Days*
Enter the number of days for an assignee to resolve the query before it becomes overdue.
If the query is not addressed before the window of days established for resolving it has been exceeded, the query icon changes to Overdue Open Manual Query
.Assigned to*
Expand the dropdown menu to select the user role that you want to address the query. Be very careful when specifying the assignee because only the users of the selected role can view the query in their tasks. Assigning the query to the wrong user role can cause a serious delay or even prevent it from resolution.
The list of available user roles for this field is study-specific and depends on settings made in the ADMIN application.
SAVE
Select
to confirm the query creation.CANCEL
Select
to dismiss all the implemented changes without saving and close the dialog.
Upon saving, the manual query opens for the selected record of a form, and Open Manual Query appears next to the
record. The assignees can review and resolve it on their side.
An item within a form contains detailed information about a specific data field. It provides accurate data captured during clinical trials. If there is certain information that is incorrect or incomplete, you can create a manual query for the selected item. This is significant so that the accountable individuals can resolve the query.
-
In the EDC application header, select the DATA ENTRY tab.
-
On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Accessing site
-
In the Subject ID column, next to the needed subject, select the link representing the subject for whom you want to create a manual query.
Figure 2. Locating your subject
-
On the Subject Visit Overview page that opens, on the left a panel with all subject visits is displayed. Expand the needed visit and in the resulting list, locate and select the form of your interest.
Figure 3. Left panel. Visits and their forms
-
On the form page that opens, next to the needed item, select the gear icon
. In the resulting menu that appears, select Open
Query 
.
Figure 4. Locating option to open query
-
In the Manual Query dialog that opens, fill in the fields as explained in the following table.
Figure 5. Editing query details
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Topic
Enter the issue on which you are creating the query: point out data discrepancies, ask a question of an addressee, provide the correct data to be updated, or else.
Expected Days*
Enter the number of days for an assignee to resolve the query before it becomes overdue.
If the query is not addressed before the window of days established for resolving it has been exceeded, the query icon changes to Overdue Open Manual Query
.Assigned to*
Expand the dropdown menu to select the user role that you want to address the query. Be very careful when specifying the assignee because only the users of the selected role can view the query in their tasks. Assigning the query to the wrong user role can cause a serious delay or even prevent it from resolution.
The list of available user roles for this field is study-specific and depends on settings made in the ADMIN application.
SAVE
Select
to confirm the query creation.CANCEL
Select
to dismiss all the implemented changes without saving and close the dialog.
Upon saving, your manual query is open, and the assignees can review and resolve it on their side.