Restore and view deleted forms
Site users can restore deleted rows of a repeating form, or the repeating section of a two-section form, as well as instances of two-section forms, and lab forms. Sponsor users can also view deleted form records.
- Ensures the transparency and auditability of data changes in repeating and two-section form records.
- Reduces the risk of data loss and errors by allowing users to view and verify deleted data that has undergone Source Data Verification (SDV) or signing.
- Enhances data integrity and compliance, increasing the visibility of deleted forms and their audit history to support data cleaning.
Before you work with this feature
To delete and restore forms as a site user, you only need to be assigned the existing permissions: View Sites, View Form Data for Subjects, and Edit Data for Subjects. No new permission is introduced for this enhancement.
As a sponsor user, you can view the deleted or restored forms if you're assigned the View Sites and View Form Data for Subjects permissions.
Details for sponsor users
- When a site user deletes a repeating form record, you can now see the new Deleted Forms link next to the repeating form's title. When they delete a two-section form instance, you can see the new Deleted History link next to the two-section form's title. Selecting either one of these links takes you to a new page where you can view all deleted repeating form rows or two-section form instances.
- You can view more details about a deleted form record by expanding the Answer & Visit History sidebar while that form record is still deleted. After a repeating form row or a two-section form instance is restored, the Answer & Visit History sidebar displays a Form Restored action, along with the reason specified for restoring the form, the date of the action, and the user who performed it.
- You can only sign, verify, freeze, lock, or raise queries against restore deleted form records.
Details for site users
- Upon deleting a repeating form row, a Deleted Forms link appears next to the repeating form's title. Upon deleting a two-section form instance, a Deleted History link appears next to the form's title. Selecting either one of these links takes you to a new page where you can view all deleted repeating form rows or two-section form instances.
- Deleted repeating form rows are displayed in a consolidated table on the Deleted Forms page. In that table, you can select restore a single repeating form row by selecting the Restore button on the Action column or select multiple rows to restore by clicking Restore All Selected.
- To better determine which repeating form row to restore, you can also select the row number in the table. This opens the deleted repeating form in a new dialog. In there, you can look at the questions in more detail and browse the Answer & Visit History sidebar.
- Deleted two-section form instances are also displayed one under the other on the Deleted History page. Each instance is numbered - that way, you have a better way of identifying which instances you may want to restore. Similar to deleted repeating form rows, you can select the checkbox next to one two-section form instance to restore it or you can select multiple instances to restore them all at once.
- Upon choosing to restore a deleted repeating form row or a deleted two-section form instance, a new dialog is displayed. On this new dialog, you're being informed of what form rows or instances you're about to restore, that you may have to create new links between this restored form and other forms or questions in your study (if needed), and you have to specify a reason for this change.
- Upon restoring a form (whether a repeating row or a two-section instance), you can return to the associated visit to view the newly restored form.
- After a repeating form row or a two-section form instance is restored, the Answer & Visit History sidebar displays a Form Restored action, along with the reason specified for restoring the form, the date of the action, and the user who performed it.
- When it comes to a deleted two-section form instance, you can only restore the entire instance, not parts of the form. For example, you cannot restore just the introductory questions in the Questions Before the Table section, you have to restore all questions included in a deleted two-section form instance.
- You cannot modify deleted form records in anyway (whether it is to raise queries clear data). You can only view or restore them. You can only update form records after you restore them.
- When you delete and restore a lab form instance, lab normal ranges are calculated again as if the lab data is newly entered. Any updates to the normal range values are displayed on the Answer & Visit History sidebar. When you look at a deleted lab form instance, the normal ranges that were applied at the point of removal will be shown.
For more information, see the Site User Guide and the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade is complete.
Impact on integrations
- 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.
- When it comes to integrations with Oracle Central Coding, if a site user deletes a coded form row, the coding results remain, and the related data is sent to Oracle Central Coding, preserving the verbatim terms and context values. When a site user restored the deleted 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.
- For integrations with Oracle Clinical One Digital Gateway and Oracle CRF Submit, restored data flows as usual.
Impact on reports
Note:
When you restore a deleted form, its data is displayed in all applicable reports again, including the Subject Data Extract.| Report or dataset | Type of change | Description |
|---|---|---|
| Subject Data report | Modified data description | Whenever a form is restored, the new
RESTORED status is displayed on the Type of
Change column.
Moreover, data related to the restored form is displayed in all other applicable columns in the report. |
| Subject Forms dataset | Modified data element | Whenever a form is restored in Oracle Clinical One Platform, the FORM_RESTORED status is displayed for the FORM_STATUS data element. data element. |
| Subject Form Items dataset | Modified data element | Whenever a form is restored in Oracle Clinical One Platform, the FORM_RESTORED status is displayed for the FORM_STATUS data element. |
| Queries dataset | Modified data element | Whenever a form is restored in Oracle Clinical One Platform, the FORM_RESTORED status is displayed for the FORM_STATUS data element. |
| All applicable CRF Submit archives and reports | Modified content |
CRF Submit still shows deleted records in the table with DELETED next to the row number. In Form View, the header displays the following message: THIS REPEATING FORM HAS BEEN DELETED. When a form is restored, in the Audit History section, the status Form Restored is displayed, DELETED is removed from the row number, and the deleted header is removed from Form View. |
Already working in a live study?
Once this feature is released, any repeating form rows or two-section form instances that were previously deleted will become available for you to review and restore.
A deleted repeating form that was verified or signed before the release of this feature can be viewed on the new Deleted Forms or Deleted History page. The deleted or restored form records are displayed as never having been verified or signed, and they will remain this way until you sign or verify them again.
Parent topic: Data collection