Update a subject number during the study conduct period

With the appropriate permission, users at a sponsor or site now have the option of updating a subject number during the study conduct period.

If you ever need to update a subject number, there is now a simple way for you to do that! With the new ability of updating subject numbers, you can perform this update at any time and with only a few clicks. Rest assured, every change you make is saved in the system and you, as well as other sponsor users, can view the audit trail of the subject numbers that you update.

Before you work with this feature

This new feature does not only impact site users. As a user administrator, you must make sure that the site user or sponsor user who updates a subject number has the appropriate permission to do so. We recommend that you only grant site users the permission to update subject numbers temporarily. After they are done with their updates, you should remove that permission associated with their role.

We also recommend that you create a custom study role for site users. The custom study role should contain the appropriate permissions for a site user, as well as the new permission called Update a Subject's Number. After a site user is done with the subject number updates, you can re-assign them with their original study role. For more information on how to create a custom study role at a study level, see Create a study role for one study.

Details for sponsor users

There are no changes in the workflow within the application. However, there are certain things that you should know:

• When a subject number is updated during the study conduct period, the system validates the new subject number to ensure it adheres to the subject number format requirements. As a best practice, we recommend you review the planned update prior to having the user's permissions updated.
• After a user updates a subject number, we recommend you work with your user administrator to ensure that the user's permission to update a subject number is revoked.
• From the moment a subject number is updated it is displayed in reports, extracts, and all other areas within the application.
• If you are assigned the Receive the Subject Number Update Notification, you receive a notification whenever a subject number is updated. The notification includes relevant details such as the site number, the original subject number, and the updated subject number.

Details for site users

Here's what you need to know about this new feature:

• On the Subjects page, when you click Manage Subjects, you see a new option called Update Subject Number(s). This is option is only active if you have the appropriate permission assigned to your role and if you have previously selected a specific site (when you have access to multiple sites).
• Upon selecting a subject and clicking Update Subject Number(s), a new dialog appears. On the Update Subject Number(s) dialog, you can perform the following actions:
  • View a subject's current subject number (under the Selected Subject column).
  • View the required subject number format.
  • Update a subject's current subject number (under the Update To column).
  • Add and remove subject numbers that you want or do not want to update.
  • Enter a reason for the update that you are making.
  • If you are assigned the Receive the Subject Number Update Notification, you receive a notification whenever a subject number is updated. The notification includes relevant details such as the site number, the original subject number, and the updated subject number.

Figure 6-4 How a user sees the Update Subject Number(s) dialog

Figure 6-5 A changed subject number in a subject's history

Reporting updates

The moment a subject number is updated, it is displayed in reports, extracts, and all other areas within the application. The Subject Events report contains the following specific updates:

• There is a new column called Previous Subject Number. This column displays the original subject number for a subject whose number was updated during the study conduct period.
• The collumn called Current Subject Number displays the newly updated subject number.
• The Event Type column displays a value of Subject Number Changed when an update has occurred.

Note:

Subject number updates will be reflected in the Oracle Clinical One Analytics custom reports and dashboards in a future release.

Impact to integrations

This feature is not compatible with all integrations configured with Oracle Clinical One Digital Gateway. If you want to change a subject's number, carefully consider how this change might impact your current integrations.

If a subject number change occurs after verbatim terms are sent to Oracle Central Coding, this will result in subject number discrepancies between the Oracle Clinical One Platform and Oracle Central Coding. Verbatim terms and coding results will still be associated with the correct subject number.

The ability to seamlessly update subject numbers without impacting your coding processes will be introduced in an upcoming Oracle Central Coding release. Until then, make sure you work with your Oracle Project Manager for additional information before changing a subject number.

Already working in a live study?

The new permissions called Update a Subject's Number and Receive the Subject Number Update Notification can be added to study roles for existing studies as soon as the upgrade completes. There is no other action for you regarding the compatibility of this feature with existing studies.