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Add query alert

Queries are created to report any discrepancies, inconsistencies, or missing data found in study files. In eTMF, you can manually create query alerts for users responsible for addressing and fixing such issues. When a query alert is triggered, the respective recipient(s) receive an email notification with all the required information on the query.

To add a query alert

  1. In the eTMF application header, select the TMF tab.

  2. In the Study List table that appears, locate the study for which you need to add a task alert. Then, in the Actions column next to it, select More more_icon.png > Query Alerts Query_alerts_icon.png.

    Accessing query alerts list
    Figure 1. Accessing query alerts list

  3. On the Query Alerts page that opens, on the workspace toolbar, select New add_new_icon.png.

  4. In the dialog that appears, fill in the fields to add a new query alert as explained in the following table.

    Adding query alert
    Figure 2. Adding query alert

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Name*

    Enter a descriptive query alert name.

    Trigger Condition

    Reminder Object*

    Select one of the following trigger conditions:

    • Query created by: when the query is created by you and a certain time has passed but no actions are taken on it, therefore, the query remains in the Open status.

    • Query holding by: when the query requires action by another user, another user is holding it, and the selected roles must be informed about the query status.

      For example, a query is created by the Data Manager (DM) and assigned to the Clinical Research Associate (CRA), therefore, the query is being held by the CRA and the query status is set to Open until further action is taken. When the CRA answers the query, the status is changed to Answered and the query is now held by the DM, until further action is taken.

    The Highest Tolerance of Query Age (Days)*

    Enter the age of the query (in days) at which the query triggers an alert.

    This option is enabled when the Query created by option is selected from the Reminder Object dropdown list.

    Reminder Roles*

    Select one or more roles that receive notifications about the query.

    This option is enabled when the Query holding by option is selected from the Trigger Condition dropdown list.

    Consolidated Reply

    Do one of the following:

    • Turn the toggle on to send a detailed response about the query to the recipient(s) when a notification is sent.

    • Turn the toggle off to disable a consolidated response. The recipients only receive a reminder notification but not a detailed response about the query.

    This option is enabled when the Query holding by option is selected from the Reminder Object field.

    Interval Days

    Enter the interval in days after which a consolidated response is automatically sent.

    This option is enabled when the Consolidated Reply toggle is turned on.

    Mail Setting

    Email Template Name*

    Select the name of the query alert email format from the dropdown list.

    The recipients receive the information in the email that is described in the selected email template.

    SAVE

    Select save_button_red.png to implement the changes.

    CANCEL

    Select cancel_button_black_white.png to discard the implemented changes without saving.

Upon saving, the query alert is added to the Query Alerts page. The added query alert is inactive by default and can be activated when required. Once activated, the system starts sending alert emails to the recipient when triggered.

In this section:

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.