How do I manually create/close queries?

Modified on Fri, 18 Aug, 2023 at 9:54 AM

Learn how to create and close queries within your study.


How do I create a query?

  1. First, you should find out whether you have the rights to open, edit and close a query.
  2. Open the study you're working with.


3.In the overview you can see next to the SIC a form symbol called "open input form". Click on it. 
4.Find the input field you wish to create a query on. Click on the button with the three dots (more actions) next to the question and select "Create query". 

5.A column will open on the right side in which you can now create the query. Describe the issue. The status is set to "Open" by default. Remember to save your changes.

6.After you have created the query, a red question mark appears next to the three dots indicating that there is an open Query on the field. You will also find a marker in the general subject overview. Read more about this in the following article: Subject overview in a study

7.After the query has been processed by an investigator or a study nurse, the color of the red question mark turns into a yellow checkmark. In addition, the color of the query mark in the subject overview of the study also changes.

8.If you now wish to close the query, click again either on the yellow marker right next to the question or on the query mark in the subject overview. A column opens. 
9.You can now close the query with another comment and change the status to "Closed".  This is what a possible communication between a monitor/data manager and investigator could look like.

10.The mark next to the question becomes a green circle indicating that there was a query on the field which is now "Closed".

11.A query can also be reopened after it has been closed. To do this, click on the query you wish to reopen, enter a comment and change the status to "open". The symbol next to the question becomes a red question mark again and the color of the mark in the subject overview changes to red as well.




⚠️ A change of the status can only be made if a comment is entered in the remark field. A saved query (or comment) can no longer be deleted.


Only one query is created on an input field (data point). Use the option to reopen the query with new requests as needed.


Queries on (S)AEs are created or closed the same way as described above for eCRF input form data. Open the applicable (S)AE form to create or close a query as described.





⭐ Fun Fact:

If you wish to make several queries in response to one question, we recommend numbering the individual queries. This way, answers from the investigator can be referred back to a specific query.


⭐ Fun Fact:

In the left sidebar, you will find the button "Queries". This displays an overview of all queries that have been created in your study. Read more about the topic "Query overview" in this article.

 




Automated queries

Automated queries can be set up in the study set-up. Similar to the validations, these appear if the set conditions apply. You can recognize an automated query by the thread message.





How does automated closing of queries work? 

All of the following conditions must be met in order for an automated query to be automatically closed by the system:

  • All previously opened queries in the thread were made by the system and are automatically marked as "non applicable" by the system after the value has been updated by a user and the query condition no longer applies
  • A user has not added a manual comment to the query thread – e.g. commenting that the input field value has been updated




When does the system mark a query as "Not applicable"? 

If a value of an input field that an automated query condition was set on is updated, with the result that the value no longer meets the query condition, the system will automatically mark the query message with a tag called "Not applicable" inside the query message thread. 









Videos


Create a query

As a monitor, if you notice missing, improbable or incorrect data during your monitoring or have a general question about an entry, you will manually create queries to communicate with the site to clarify any discrepancies or inconsistencies found in the data. This short video shows you how to create and save a query.




Update/close automated queries

Under certain conditions, the system may generate automated, predefined queries. In this video, we will demonstrate how these automatically generated queries are closed and can in addition be closed and edited manually if needed, for example by a monitor.

 


 

 


✉️ Still have questions? Please contact your study coordinator.

Was this article helpful?

That’s Great!

Thank you for your feedback

Sorry! We couldn't be helpful

Thank you for your feedback

Let us know how can we improve this article!

Select at least one of the reasons
CAPTCHA verification is required.

Feedback sent

We appreciate your effort and will try to fix the article