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Create subject unblind request alert

A subject unblind request refers to the process when authorized users request access to a subject's treatment assignment information, typically undertaken in situations where knowledge of the assigned treatment is deemed crucial for medical or ethical reasons. A subject unblind request alert is a customizable notification mechanism that generates an email to inform relevant parties about the most current unblind status of any study subject.

You can create only one subject unblind request alert per each transaction type there is, for example, when an unblind request is submitted or approved. The purpose of a subject unblind request alert is to ensure the timely awareness of responsible IWRS users about the developments in the subject unblinding process within the study.

The following figure is an example of the email that an eClinical user can receive after the subject unblind request alert has been properly configured and a subject unblind request has been submitted.

Subject unblind request alert example
Figure 1. Subject unblind request alert example

To create a subject unblind request alert

  1. In the IWRS application header, select the ALERT tab.

  2. On the page that opens, from the left pane, select the subtab corresponding to the alert category of your interest.

    Accessing alert settings
    Figure 2. Accessing alert settings

  3. From the workspace toolbar of the Subject Unblind Request Alert table that appears, select Add add_new_icon.png.

    Selecting option to add subject unblind request alert
    Figure 3. Selecting option to add subject unblind request alert

  4. On the page that opens, configure a subject unblind request alert as explained in the following table.

    Configuring subject unblind request alert
    Figure 4. Configuring subject unblind request alert

    Tip

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

    Element

    Details

    Basic Information

    Alert Name*

    Enter a name for the subject unblind request alert that you are creating.

    Transaction Type*

    Select one of the following transaction types:

    • Unblind Request Submitted: triggers an alert after an authorized user requests to unblind a subject.

    • Unblind Request Approved: triggers an alert after an authorized user approves the subject unblinding.

    • Unblind Request Revoked: triggers an alert after an authorized user cancels the subject unblinding.

    • Subject Unblinded: triggers an alert after an authorized user unblinds a subject.

    Mail Settings

    Recipients

    Select either of the following options:

    • Select Username: to expand the list of system users and select the ones to receive an alert email. To remove a user from recipients, clear the checkbox next to their name.

    • Select by Role: to expand the list of system user roles and select the ones to receive an alert email. To remove a user role from recipients, clear the checkbox next to its name.

    You can specify users and roles together.

    Subject*

    Enter the subject of the email. You can also start typing with the opening brace "{" to open the list of predefined values that you want to include in the email subject, for example, the subject ID or study name.

    Content*

    Enter the text of the email. You can also start typing with the opening brace "{" to open the list of predefined values that you want to include in the email content, for example, the site name or lifecycle.

    SAVE

    Select save_button_red.png to create a subject unblind request alert after it has been configured.

Once saved, the subject unblind request alert for the study is created. Whenever a subject unblind request acquires a specific status, an email is sent to the corresponding recipients.

In this section:

A participant who is enrolled in a clinical trial and assigned to the site.