Queries can be used by investigators and monitors to raise queries on the data collected by the data entry staff in case the monitors find something strange, peculiar, or missing values/answers.
Should you have permission to create queries, queries can be created when viewing a filled-out form. Click on the three dotted lines to the right of the question of interest. This will make a text box appear where you can write your query comment.
Queries can be created on any form (AE form, Image chart, and regular form) where ever they are used (Data event, Unscheduled event, and Adverse Event Module)
Note: Currently it is not possible to create queries in the SMART-TRIAL medication module.
There are three ways to view a query:
When a query is created, you are notified by the bell in the top right corner. If you click on the Query Notification you will be taken directly to the form and query, where you can respond to the query.
From Site Overview
You can also view the query by navigating to the specific form and find the query next to the question the query was submitted to. Open queries are visible in the site overview, as small flags placed on the data events.
To view the query details and/or respond to the raised query navigate to the question related to the query of interest by clicking the relevant data event square in the individual site overview and choose “View Form Answers” from the side menu.
Navigate to the Form containing the query by clicking the form marked with a flag.
All the raised queries in the chosen form will be shown below the related question.
To view all queries, use the left side menu and click on Queries to access the query list.
This will bring you to the query overview.
Subject ID can be clicked in the query list, to take you directly to the subject's profile.
On the right, you can click on the first of the marked Action buttons “Go to Form” for a quick path to the query. If a query is created by a mistake or no action is necessary you can close the query by clicking the "Close query" button, a text box will appear, and a descriptive text has to be filled in before the query can be closed.
Query List Filters:
By use of filters, you are allowed to sort and show your queries based on whom the queries are created by, the status of the queries (Open, Responded & closed), Subject, Site(s), Data event(s), specific form(s) or search for a specific query text. As an example, you can also choose to only view open queries by using the status filter. An overview of the filters is provided below:
Respond to Queries:
To respond to the query, you navigate to the related question to the query by one of the 3 aforementioned ways. Here you can view the details of the query and choose to "respond with change" or "Respond without change".
If you choose to "respond with change", the question answer is opened for editing, click submit once the value is correct and respond to the query. Should you choose to decline the query click "respond without change" and give a reason for declining the query. This continues until both parties are satisfied with the question answer.
Adverse Event Module
It is only possible to respond with changes to queries on questions you have permission to answer. E.g.: Only users with Sponsor permissions can respond to sponsor specific questions in an AE report.
Queries can be closed by users with the "Query" permission.
There are two ways to close a query, depending on the status of the query.
If the query has just been opened, and not yet responded to, the query can be "closed" either via the queries list, or from within the form.
If the query has been responded to by site personnel, the query can be "accepted".
Both ways of closing the query will require a comment to be input. The comment will be visible on the query.