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Revoke 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 dispose of items themselves by creating destruction batches—bundles of items that are to be destroyed together—and approving their disposal. Once approved, the items within the batch are considered destroyed. However, if any mistake is made and the batch needs to be reconsidered, you can at any time revoke the item batch destruction operation.

To revoke an item destruction batch at a 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.

  4. On the page that opens, select the Destruction Batch tab.

    Accessing item destruction batch list at site
    Figure 2. Accessing item destruction batch list at site

  5. In the Destruction Batch table that appears, locate the previously created batch in the Approved status that you need to revoke. Then select its batch number.

    Selecting item destruction batch to revoke
    Figure 3. Selecting item destruction batch to revoke

  6. On the Destruction Batch page that opens, review the details of the items for the initiated destruction. Then select revoke_button_red_white.png.

    Revoking item destruction batch
    Figure 4. Revoking item destruction batch

  7. In the Revoke dialog that opens, provide your credentials to confirm your action as explained in the following table.

    Providing credentials for destruction batch revoke
    Figure 5. Providing credentials for destruction batch revoke

    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.

    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, close the dialog, and return to the Destruction Batch page.

Once saved, the destruction operation is revoked, and the status of the item batch changes to Initiated. Now, you can do one of the following:

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.