How is my study's data impacted when data is deleted and restored?

Whenever a form record is deleted and restored, the deleted and restored data is highlighted appropriately in reports, archives, and in other User Interface (UI) areas of the application.

Note:

If you want to learn more about the process of restoring a form record, see the following:

Data that is signed, verified, frozen, or locked

When a site user deletes form records—regardless of whether the data was signed, verified, frozen, or locked—you can still view them on the Deleted Forms page (for deleted repeating form rows) or the Deleted History page (for deleted two-section form instances). The following also apply:
  • When a site user deletes form records that contain signed or verified data, the status of all impacted questions, form records, and associated visits is updated to either Unsigned, Unverified, or both. On the Deleted Forms or Deleted History page, while the form records remain deleted, you can see the related actions on the Answer & Visit History sidebar. You cannot see certain status icons next to the form records, whether the records are deleted or restored. For example, icons indicating that a form is unverified, unsigned, unlocked, or unfrozen will no longer appear in either case. However, if a form record is restored, status icons such as complete or incomplete will appear again.
  • If a form record is unlocked or unfrozen before being deleted, its status (Unfrozen and Unlocked) is displayed in the Answer & Visit History sidebar.
  • You cannot raise queries against deleted form records, but you can raise queries as soon as the form records are restored.
  • When a site user restores a deleted form record that has a signature configuration applied to it, if a signature is required, there may be a delay before you can sign the newly restored configuration. For more information, see About signature configurations.

Data that contains JavaScript rules or predefined rules

Here's what you need to know when it comes deleted or restored forms that contain JavaScript or predefined rules (such as rules that dynamically display data):
  • If any of the deleted questions are used as variables in a rule for an automated query or a calculation rule, once the question is restored, the associated rule runs again.
  • If any of the deleted questions are configured as the determining question for a dynamic rule, the dynamic rule is evaluated in the system and any dynamically-displayed questions, forms, sections, or visits are shown again, if applicable.
  • If a study designer applies an Advanced Study Versioning (ASV) change to deleted questions, the change will be reflected on the Deleted Forms or Deleted History pages, showing how the modified form records appear if restored.

Restored data in reports, archives, and Oracle Clinical One Analytics datasets

Whether you're a data manager or another sponsor user that works with reports, archives, or datatsets, the first thing that you should know is that once data is restored in the system, that data is displayed across all applicable reports again, including the Subject Data Extract. Additionally, here's how restored data is highlighted in specific reports:
  • When a form record is restored, the RESTORED status is displayed on the Type of Change column in the Subject Data report.
  • When a form record is restored, the Subject Forms, Subject Form Items, and the Queries dataset display the Form Restored status for the FORM_STATUS data element.
  • For an Oracle CRF Submit archive or report, in the Audit History section, the status Form Restored is displayed. The label DELETED is removed from the row number and the deleted header is removed from Form View.

Deleted and restored data in integrations

If your study is integrated with any of the following applications, here's what you may need to know:
  • For any integrations with Oracle DMW, data on deleted form records continues to be displayed in the DELETED column. When a form record is restored, the flag changes from Y to N.
  • For integrations with Oracle Clinical One Digital Gateway and Oracle CRF Submit, restored data flows as usual with the following exceptions:
    • The restoration of deleted repeating forms is not currently supported by integrations that send data to Oracle Clinical One Digital Gateway, such as the Multi IWR or Data Intake integrations.
    • For the CTMS integration, data generated by deleting or restoring a form will not be integrated, unless a visit completion or data update event is triggered by these actions.
  • When it comes to integrations with Oracle Central Coding, the following apply:
    • If a site user deletes a repeating form row for a coded verbatim term, the coding targets remain visible when viewed on the Deleted Forms or Deleted History page, and the term is deleted (or hidden) in Oracle Central Coding. If a site user restores the repeating form row, the coding targets are cleared and a message is sent to Oracle Central Coding to restore the verbatim term to Active, so it can be re-coded.
    • When a site user restores a form record, Oracle Clinical One Platform clears the coding target fields. After that, Oracle Central Coding follows the normal coding process to return the coding value, as usual.