Skip to main content

Return site items for destruction

A site is the location where the subject treatment and item dispensation occurs. In a course of a clinical trial, the need may arise to return dispensing items from a study site to the depot. In IWRS, you can return both product units and container units for destruction.

Some of the reasons for returning items for destruction include expired products that are no longer suitable for use and cannot be administered to subjects; items may become damaged or compromised during storage or transportation, rendering them unsuitable for use; in the event of study termination, the remaining items must be returned to the depot for destruction as it is a part of the overall study closure process.

To return site items for destruction

  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 for Destruction.

    Selecting to return items for destruction
    Figure 3. Selecting to return items for destruction

  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 the product and container units with the To be Returned disposition status are displayed in this table.

    2. In the Destination field, make sure that the depot, where the items need to be delivered for destruction, is preselected. For the depot to be indicated as the destination, it needs to be set as a return depot in site settings first.

    3. Select initiate_request_button_red_white.png.

    Creating return shipment with items for destruction
    Figure 4. Creating return shipment with items for destruction

  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 and select save_button_white_red.png to update the return request.

    Approving return shipment with items for destruction
    Figure 5. Approving return shipment with items for destruction

    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 go back to the site inventory.

    Canceling return request
    Figure 6. Canceling return request

  7. After ensuring that all return request details are correct, select approve_button.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 for destruction 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.