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Create lot alert

A lot is a batch of items (drugs) that have common characteristics. In IWRS, there are two types of lots—a packaging lot and a manufacturing lot.

Important

The lot alert functionality applies only to packaging lots since these are used for all system processes in IWRS, whereas the manufacturing lots exist only for statistics tracking.

Once a new packaging lot is created and different events occur with it—from being released to the depot or site to item expiration getting closer—there are responsible personnel who would benefit from getting notified of all such events.

For instance, the principal investigator (PI) of the site would benefit from being updated on the packaging lot expiration getting closer. This helps manage their site supply and maintain uninterrupted dispensation.

In this section, you can learn how to create and configure lot alerts for different system events—packaging lot creation, editing, release, and so on.

Creating a lot 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 1. Accessing alert settings

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

    Adding lot alert
    Figure 2. Adding lot alert

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

    Configuring lot alert
    Figure 3. Configuring lot alert

    Tip

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

    Element

    Details

    Basic Information

    Alert Name*

    Enter a name for the lot alert that you are creating.

    Blinding*

    Select one of the following blinding types:

    • Blind: select this type if you want both blinded and unblinded users to be recipients of the alert.

    • 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:

    • Lot Created: triggers an alert when a new packaging lot is created in the system.

    • Lot Released: triggers an alert when the packaging lot items are released to their destination.

    • Lot Edited: triggers an alert when the packaging lot details are modified.

    • Lot Revoked: triggers an alert when the packaging lot release is revoked.

    • Lot Expired: triggers an alert when the items within the packaging lot are getting close to their expiration or expiring—depending on the buffer settings. This alert triggers for every expiration date from the packaging lot—the default and the additional ones.

      You can learn more about the lot expiration dates in the Manage packaging lot expiration dates section.

    Buffer (days)

    The buffer setting is only available for the Lot Expired transaction type.

    Threshold

    Enter the number of days before the expiration date that triggers the alert. Once one value is entered, a new row appears for you to set multiple buffer periods and trigger several alerts as the packaging lot gets closer to expiration.

    For instance, you can notify the responsible personnel about the packaging lot expiration 30 days before, 15 days before, and then zero days—the expiration day.

    Select the minus symbol minus_circled_icon.png to remove extra rows.

    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.

    The users and roles available for selection depend on the blinding setting. 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 variables 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 variables that you want to include in the email content.

    SAVE

    Select save_button_red.png to create a lot alert after it has been configured.

Once saved, the alert is created in the Active status. The recipients are notified via email upon each system event of the configured conditions.

Tip

The alert starts triggering right upon creation. Thus, if you want to delay its start, consider temporarily inactivating the alert.

In this section:

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.