Answering a query

You answer queries on the Query List page or in the Query Detail dialog box. You can go directly to the Query List page and work through the list of queries, or you can start at the Patient Summary page and view the patient queries in relation to visits and forms.

An answer to a query might involve updating the data entered or responding without changing the data because the data is correct. Site users, typically investigators and clinical research coordinators, answer queries.

The site response you select when you answer the query for the item appears on the Audit Trail page.

Select Queries ().
The Query List page appears.
Filter the queries as described in Filtering and sorting the Query List.
Select an open query.
The query information appears on the Query Detail page on the Answer tab.
In the Change Data field, change or leave the value.
From the Site Response drop-down list, select the reason for the changed answer.
If you select Other, type the reason in the Site Response Other Text box.
To add a note about the query, enter it in the Notes text box.
Click Submit.
The application displays a confirmation message in green type in the middle of the page.

If the answered query is an automatic query, its status changes to Approved, and the OutcomeLogix application removes the query from the Query List page. If the answered query is a manual query, its status changes to Answered. The reason for change appears in the Reason column of the Audit Trail page.

Note: After you answer a manual query, someone must approve the query or reissue the query. A sponsor user, typically the clinical data manager or medical monitor, performs this action.

Select Patients ().
The Patient List page appears.
Click the Summary link for the patient.
The Patient Summary page appears.
Select a visit, form, or item with an open query.
1. Expand a visit by clicking the arrow next to the visit name.
  The forms in the visit appear.
2. Expand a form by clicking the arrow next to the form name.
  The items on the form appear.
3. View the query associated with an item by clicking the arrow next to the item name.
Select the query by selecting the checkbox to the left of the item.
Click the Response Query icon ().
- If you selected a visit with an open query, the Query List page appears listing all the forms with queries within the visit.
- If you selected a form with an open query, the Query List page appears listing the queried items within the form.
- If you selected an item with an open query, the Query List page appears listing the queried item.
Select the query.
The query information appears on the Query Detail page on the Answer tab.
In the Change Data field, change or leave the value.
From the Site Response drop-down list, select the reason for the changed answer.
If you select Other, type the reason in the Site Response Other Text box.
To add a note about the query, enter it in the Notes text box.
Click Submit.
The application displays a confirmation message in green type in the middle of the page.

Open the form. For more information, see Entering and editing data on a form.
Click an Open query status icon (). To see the query text, hover over the Open query status icon.
The Query Detail dialog box opens.
In the Change Data field, change or leave the value.
From the Site Response drop-down list, select the reason for the changed answer.
1. If you select Other, type the reason in the Site Response Other Text box.
2. To add a note about the query, enter it in the Notes text box.
Click Save.
The application updates the Status field at the top of the form.
To view the history of the query, click the View down arrow and click History. For more information, see Viewing the history of a query.
To view the notes attached to the query, click the View down arrow and click Note.