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Return available site items

A site is the location where the subject treatment and item dispensation occurs. In the course of a clinical trial, you might need to return items from a site to the depot. In IWRS, you can return available product units and container units to the respective depot so they can be reused elsewhere.

Some of the reasons for returning available items include the excess inventory if the site has dispensed more items than are required for a specific period or patient cohort; protocol amendments that imply adjustments to the treatment regimen, dosage, or eligibility criteria; subject discontinuation or withdrawal that results into the need to return items associated with those patients.

To return available site items

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

  2. In the Site List table that opens, select the needed site.

    Selecting site to view details
    Figure 1. Selecting site to view details

  3. In the left pane of the page that opens, select Return.

    Accessing site item return
    Figure 2. Accessing site item return

  4. In the Request table that appears, from the workspace toolbar, select Add icon_add.png and then Return Available Items.

    Selecting to return available items
    Figure 3. Selecting to return available items

  5. On the New Return Shipment page that opens, perform the following steps:

    1. In the Item Unit List table, select checkboxes next to items that you want to return.

      Important

      Only product units with Available and container units with Complete disposition statuses are displayed in this table.

      If the container unit is Open, in this table, you can see the product units from the container with the Available disposition, but not the container itself.

    2. In the Destination field, select the depot—supply or return one—where the items need to be delivered.

    3. Select initiate_request_button_red_white.png.

    Creating return shipment with available items
    Figure 4. Creating return shipment with available items

  6. Once the return request has been initiated, you can view the details of this request on the same page. If needed, you can add more items to the list or change the destination depot and select save_button_white_red.png to update the return request.

    Approving return shipment with available items
    Figure 5. Approving return shipment with available items

    Tip

    The return requests can be canceled by selecting cancel_request_button_white_red.png and then confirming this action. All items from the canceled return request will become again available in the site inventory.

    Canceling return request
    Figure 6. Canceling return request

  7. After ensuring that all return request details are correct, select approve_button_red_white.png.

  8. In the Approve dialog that appears, enter your eClinical platform password.

    Important

    The details you need to provide for action confirmation depend on the authentication method configured for you in the system—via SSO or via providing your login and password.

    Approving return request
    Figure 7. Approving return request

    Tip

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

    Element

    Details

    Username or Email*

    Enter your username or email that you use to log in to the eClinical applications.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    The button is only available if you use the authorization method via SSO.

    Code*

    Enter the temporary PIN code that you received via email.

    The field is only available if you use the authorization method via SSO.

    Password*

    Enter the password that you use to log in to the eClinical applications.

    The field is only available if you use the authorization method by providing your login and password.

    Reason*

    Enter a valid reason for granting/denying the user role access to unblinded subject data in the IWRS application.

    SAVE

    Select save_button_white_red.png to confirm your action with your signature and save the implemented changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes and close the dialog.

    Important

    For security, the system logs you out after three failed attempts to confirm your identity with a password or code.

Once approved, the return request is created and a corresponding shipment becomes automatically generated by the system. You now need to confirm this shipment so the items can be sent or revoke the shipment if the item return is no longer required.

In this section:

Medical care given to a subject to mitigate or cure an illness, injury, or reduced health status. In a clinical trial, treatment may include prescribed drugs, biologics, devices, physical or psychotherapies, and such other procedures.

In eClinical, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

A warehouse that is used to store and distribute items (drugs) to another destination (other depots or sites).

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the product unit in the IWRS system is item unit.

A hierarchical unit used to group and manage investigational products (IMPs) and placebos for shipping and inventory purposes. For example, large boxes and medium boxes.