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Create item destruction batch at site

Item destruction refers to the process of disposing of or destroying an investigational product or other unused medication when they are no longer needed, damaged, or for another reason. It is an important step in ensuring the proper management and disposal of these items to maintain compliance with regulatory requirements, participant safety, and confidentiality.

In IWRS, the sites involved in your trial for which the item destruction is enabled can destroy items themselves by creating destruction batches—bundles of items that are to be destroyed together—and approving their disposal.

Important

To enable this functionality, turn on the Enable Destruction Batch toggle on the Study Information page.

By destroying an item from the Destruction page of IWRS, you reflect the actual physical action taken towards the drug at a certain site. This helps to keep the database up-to-date for tracking and compliance reasons.

Create an item destruction batch at the site

  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. On the page that opens, in the left pane, select Destruction.

    Accessing item destruction for site
    Figure 2. Accessing item destruction for site

  4. In the Ready for Destruction table that appears, select the checkboxes next to the items that you want to add to the destruction batch. Then from the workspace toolbar, select Destroy trash_can_icon_red.png.

    Selecting items to create destruction batch
    Figure 3. Selecting items to create destruction batch

  5. In the Destroy dialog that opens, enter the details for the destruction batch as explained in the following table.

    Creating item destruction batch
    Figure 4. Creating item destruction batch

    Tip

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

    Element

    Details

    Tracking Identifier

    Enter a number or character combination that helps identify the destruction batch and trace it for future reference.

    Destruction Date*

    Select the actual date when the items added to the batch were destroyed.

    You cannot select the date past the current one to avoid registering future destructions beforehand and only allow already performed operations to be recorded in IWRS.

    Description

    Enter a comment to provide any auxiliary details on destroyed items.

    SAVE

    Select save_button_red.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes without saving, close the dialog, and return to the Ready for Destruction table.

Once saved, the batch of items for destruction is created and becomes available for approval under the Destruction Batch page.

Important

If the Approve Batch permission is granted to your user role in ADMIN, you are redirected to the batch approval page directly upon batch creation.

In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.