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Remove signature from depot inventory reconciliation list

An inventory reconciliation at the depot is a practice mostly performed by the clinical research associate (CRA) to ensure the number of items to be destroyed is valid according to the quantity established at reconciliation by the site that returned items for destruction.

Once all the required reconciliation activities are performed at the depot, the CRA in charge must sign the reconciliation list to verify it. The signature disables all the further amendments to ensure the integrity of reconciliation results.

However, if new details on item count become available and it is required to change the reconciliation results, there is an option to retrieve the electronic signature, thus enabling amendments.

Tip

You can review the signature details to see who signed the reconciliation in the first place and consult them regarding unsigning if required.

To remove a signature from the depot inventory reconciliation list

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

  2. On the Depot List page that opens, in the table, select the depot code of your interest.

    Selecting depot to open its details
    Figure 1. Selecting depot to open its details

  3. On the page that opens, from the left pane, select Inventory.

  4. On the inventory page, from the contents panel, select Reconciliation.

    Accessing depot inventory reconciliation
    Figure 2. Accessing depot inventory reconciliation

    Tip

    Once you open the reconciliation page for a depot, you can use the breadcrumbs navigation to switch between different depots' reconciliation lists without returning to the Depot List page.

    Switching depots from breadcrumbs
    Figure 3. Switching depots from breadcrumbs

  5. From the workspace toolbar of the Reconciliation page, select Unsign unsign_icon.png.

    Unsigning depot reconciliation list
    Figure 4. Unsigning depot reconciliation list

  6. In the Unsign dialog that appears, provide your credentials as explained in the following table.

    Providing credentials to retrieve signature
    Figure 5. Providing credentials to retrieve signature

    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.

    Submit Electronic Signature

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

    x_icon.png

    Select the cross icon to discard the action, close the dialog, and return to the Reconciliation page.

Once the signature is retrieved, you can perform depot reconciliation as required.

In this section:

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.