Approve 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.
The review and approval stage is required to ensure an additional tier of security for drug disposal procedures at sites and respective records maintenance in the IWRS system.
Important
To approve the destruction of item batches in IWRS, you must have the Approve Batch permission granted to your user role in ADMIN.
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In the IWRS application header, select the SITE tab.
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In the Site List table that opens, select the needed site.
Figure 1. Selecting site to view details
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On the page that opens, in the left pane, select Destruction.
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On the page that opens, select the Destruction Batch tab.
Figure 2. Accessing item destruction batch list at site
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In the Destruction Batch table that appears, locate the batch in the Initiated status awaiting your approval. Then select its batch number.
Figure 3. Selecting item destruction batch for approval
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On the Destruction Batch page that opens, review the details of the items for the initiated destruction. Then select
.
Figure 4. Approving item destruction batch
Tip
At the approval stage, you can update the actual item destruction date and tracking number if, upon batch creation, any mistakes were made. You can also add an optional batch description if needed.
Figure 5. Updating item destruction batch details
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In the Approve dialog that opens, provide your credentials to confirm your action as explained in the following table.
Figure 6. Providing credentials for destruction batch approval
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
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
to confirm your action with your signature and save the implemented changes.CANCEL
Select
to discard the changes, close the dialog, and return to the Destruction Batch
page.
Once saved, the status of the item destruction batch changes to Approved, thus, the destruction of items within the batch is considered completed.