Create randomization alert
Randomization is a process to help you avoid potential bias in the selection and allocation of subjects arising from the predictability of treatment assignments. From a statistical perspective, randomization provides unbiased estimates of error variance and independence of errors. A randomization alert is a customizable notification mechanism that generates an email to inform relevant parties when a normal or forced subject randomization succeeds or fails.
The purpose of a randomization alert is to promptly notify the responsible IWRS users about the transaction type success or failure. You can only create one randomization alert per each transaction type, for example, when a randomization fails.
Important
An email is sent to the eClinical user after the randomization alert has been properly configured and a normal or forced randomization has succeeded or failed. A randomization alert is only sent when a subject is randomized.
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In the IWRS application header, select the ALERT tab.
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On the page that opens, from the left pane, select the subtab corresponding to the alert category of your interest.
Figure 1. Accessing alert settings
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From the workspace toolbar of the Randomization Alert table that appears, select Add
.
Figure 2. Selecting option to add randomization alert
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On the page that opens, configure a randomization alert as explained in the following table.
Figure 3. Configuring randomization alert
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Basic Information
Alert Name*
Enter a name for the randomization alert that you are creating.
Blinding*
Select one of the following blinding types:
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Blind: select this type if you want both blinded and unblinded users to be recipients of the alert.
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Unblind: select this type if you want only unblinded users to be recipients of the alert.
Transaction Type*
Select one of the following transaction types:
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Randomization Succeed: triggers an alert when a randomization succeeds.
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Randomization Failed: triggers an alert when a randomization fails.
Randomization Type(Multi)*
Select one of the following randomization types:
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Normal: triggers an alert when the subject is randomized as a result of normal randomization.
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Forced: triggers an alert when the subject is randomized as a result of forced randomization.
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Select all: triggers an alert when the subject is randomized as a result of both forced and normal randomization.
Mail Settings
Recipients
Select either of the following options:
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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.
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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 expand the list of predefined values that you want to include in the email subject.
Content*
Enter the text of the email. You can also start typing with the opening brace "{" to expand the list of predefined values that you want to include in the email content.
SAVE
Select
to create a randomization alert after it has been configured. -
Once saved, the randomization alert for the study is created. Whenever a randomization succeeds or fails for this study, an email is sent to the corresponding recipients.