Workflow for updating a subject number during the study conduct period

There might be situations when you (as a sponsor user) or your site staff are required to correct one or multiple subject numbers.

A site user is only allowed to update a subject number when assigned with the appropriate permission.

For a site user to properly update a subject number, sponsor users and site users must collaborate in an efficient manner.

How updating a subject number works

Note:

The subject number displayed in the audit trail is the number assigned to a subject when the update occurred in the system. While looking at a subject's audit trail, use their GUID (not their updated subject number) to ensure that all changes relate to the same subject.

Oracle Clinical One Platform automatically assigned a subject number and a site user updates subject numbers in a way that may create a gap in the subject number sequence, the application fills in that gap when the next subject is added. In other words, a skipped subject number will not be the next available subject number. Subject numbers will be assigned to subjects sequentially starting with the highest subject number.

Once a user updates a subject number, that change is reflected throughout the application: on the Subject History side panel, on the Subjects page, in any integrations, subject extracts, and reports that contain subject numbers.

Related to reports, the only exception can be found in the CRF Submit archives. For example, if a subject is transferred from site A to site B, and the subject number is updated at site B, archives generated in association with site A will include the subject number as it was at the time of the transfer, instead of displaying the updated subject number.

Workflow for updating a subject number

After a site user adds a new subject in a study or a subject number is assigned by an integrated third-party application, either the site or sponsor user may recognize that there was a data entry error for one or more subject numbers.

Note:

Consider the following notes before updating a subject number:

• If you set any of these two settings (Allow Site to Enter Subject Number and Allow Subjects to be Manually Added) to No, after they were previously marked as Yes, this may prevent you or a site user from updating a subject number. When the abilty to add subjects and their numbers is changed from being manual to automated this interferes with the way you update subject numbers.
• If you plan on updating the Subject Numbering Setting setting during the study conduct period, make sure you re-configure this setting after subject numbers are updated in the system.
• Before the first subject is added in a study, you should carefully review the study settings impacting a site user's ability to add subjects and how they enter their subject numbers. This reduces the probability of updating a subject number after the settings are updated and the subject is already created.

Step	Description
A user administrator must grant the user the appropriate study role.	After the data entry error is recognized, you must temporarily grant a user the Update Subject Number after Creation permission so they can perform the update. We recommend you create a custom study role (perhaps at a study level) that contains this specific permission, as well as all other permissions that a site user may require to view and edit data in a study. To make sure both the site and sponsor users are notified of the subject number updates, assign them the Receive the Subject Number Update Notification permission. For step-by-step instructions, see Create a study role for one study.
A site user or sponsor user makes the appropriate subject number updates.	On the Subjects page, a user can select one or multiple subjects and correct the data entry errors that were identified. For step-by-step instructions, see Update a subject number.
A sponsor user reviews the updates	After a site user or another sponsor user completes their subject number updates, you must sign into the application and check the updated subject numbers to ensure they are correct. Upon selecting a subject, you can view the subject number update on the Subject History side panel. To get notified of a subject number update, make sure that you are assigned the Receive the Subject Number Update Notification notification.
A user administrator updates the site user's study role again	After a sponsor user validates the subject number updates, you can then remove a site user's custom study role and assign them with their previous site user study role. It is important to ensure that the site user no longer has the permission to update a subject number.

How a subject number update may impact integrations

The table below describes the possible use cases for how a subject number may impact your configured integrations.

Note:

While updating a subject number is possible when your study is integrated with other applications, we advise you to carefully consider the impact of a subject number change on any of your current integrations. Reach out to your Oracle Project Manager for additional information before changing a subject number.

Use case	Description
You are required to swap two subject numbers in Oracle Clinical One Platform and the study is integrated with Oracle InForm.	If two subject numbers need to be replaced with one another in Oracle Clinical One Platform, the setting to allow duplicate subject numbers in Oracle InForm should be set to Yes. If not, in Oracle Clinical One Digital Gateway the job fails and subsequent jobs are blocked until the issue is resolved in Oracle InForm. Note: Work with your Oracle Project Manager to ensure Oracle InForm is configured correctly prior to swapping subject numbers in the Oracle Clinical One Platform.
You cannot update a subject number in Oracle Clinical One Platform when your study is integrated with Veeva Vault CTMS. For more information about this integration, see Send subject enrollment information to Veeva Vault CTMSSend subject enrollment information to Veeva Vault CTMS.	If a subject number is updated in Oracle Clinical One Platform, the subject number change event is not processed for the Oracle Clinical One Platform to Veeva Vault CTMS integration. This will create subject number discrepancies between the two systems. As a best practice, we recommend you do not update a subject number for a study that is integrated with Veeva Vault CTMS.
You cannot update a subject number in Oracle Clinical One Platform when an inbound integration is configured. For more information about this integration, see Load lab results and other data into Oracle Clinical One Platform.Load lab results and other data into forms in Oracle Clinical One Platform	If a subject number is updated in a third-party system, the data intake integration cannot process a subject number update in Oracle Clinical One Platform. In this case, the subject number must be updated in Oracle Clinical One Platform, as well. Not doing this can result in failed data import or data being imported for the wrong subject.
You update a subject number after verbatim terms were already coded in Oracle Central Coding.	There is no impact. The Oracle Central Coding user interface, reports, and exports reflect the updated subject number.