About deleting, restoring, and viewing deleted form records

Restoring a form record makes its data accessible for modification in the subject's forms. Additionally, the restored data is marked in various UI areas, including the Answer & Visit History sidebar and relevant reports.

Note:

Do you want to restore any deleted record forms? See Restore deleted forms.

Linked form records and predefined rules

The following apply when you delete or restore data that contains links or predefined rules (such as dynamic rules):

• Deleted form links won't be restored; recreate them after restoring the deleted forms. For step-by-step guidelines, see Link forms.
• Deleted rows from repeating forms with label questions can be viewed and restored, even with rule changes. For example, deleted rows remain available for restoration if the Show Section rule is re-triggered or the lab is updated.
• Deleted rows from repeating forms or two-section forms associated with not-triggered visits (whether it is a dynamic visit or a Screen Failure, Study Completion, or Withdrawal visit) can be viewed and restored if the visit is triggered.
• If a Show Section predefined rule is configured for a two-section form, and the form section isn't displayed yet, the link to the Deleted Forms or Deleted History page is unavailable until the form section is triggered.

Data collection workflows

These rules apply to specific data collection workflows, such as uploading documents or integrating EHR and safety data.

• Deleting a safety case form flagged as a Serious Adverse Event (SAE) cancels the SAE. Restoring the form re-opens the original safety case. If you restore a form record associated with a safety case, you may need to re-associate it manually.

  Note:

  If there are incomplete and required questions in the restored form, don't submit the safety case until you enter the required data. If the triggering criteria is no longer met, don't re-open the safety case.
• Deleted form records with attached documents can be viewed on the Deleted Forms page. Restoring a form record also restores the attached documents.
• Restoring a form record with EHR data displays the Imported from EHR tag unless you update the data after restoration.
• Restoring a form won't open a new safety case if the triggering condition is met unless the value is modified after restoration. For more on safety cases, see About collecting adverse event data when integrating with Safety.

Data that contains manual queries

When you delete form records that contain queries, the manual queries associated any of the form's data are handled in a specific way:

Note:

Consider the following:

• Before deleting a repeating form (or any form), ensure any queries or data you wish to retain have been documented externally, as this action is irreversible within Oracle Clinical One Platform.
• Deleting a single instance of a repeating form affects only queries tied to that particular instance; queries for other instances remain unless those are also deleted.

• Manual queries linked to the deleted repeating form instance are also deleted. This is because the underlying data they referenced no longer exists.
• Once the repeating form instance is deleted, any open or resolved manual queries associated with that instance are automatically removed from the system and cannot be recovered.
• System-generated queries tied to data validation or edit checks involving the deleted instance are handled similarly - they are also deleted due to the data removal.

Data that is signed and verified

If you delete and restore form records that contain data that's signed or verified, here's what may happen:

• If you delete 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. If you restore form records that were previously Unsigned or Unverified after you deleted them, their status is preserved as Unsigned or Unverified.

  On the Deleted Forms or Deleted History pages, while the form records remain deleted, you can see the related actions on the Answer & Visit History sidebar. You cannot see any related icons next to the form records, whether the form records are deleted or restored. For example, you won't see icons related to the deleted form records being complete, incomplete, signed, or verified.

Data that is frozen or locked

If you delete and restore form records that contain data that's locked or frozen, here's what may happen:

• You cannot delete a form row or instance that is locked. If a form is locked after any of its records are deleted, you cannot restore the removed records, even if you can view them on the Deleted Forms or Deleted History pages. In the case of a repeating form, if all rows were deleted and the visit is locked, at least one question in the visit should be unlocked so that you can restore the deleted repeating form row. If at least one instance of a form is not locked, you can restore the deleted records.
• You can still view a deleted form record that's locked, but you cannot restore it.

  If you must restore form records that are currently locked, work with your Clinical Research Associate (CRA) to unlock any required form records.

• You can still restore deleted form records, even if the form is frozen. For example, if you previously deleted Record 1 and Record 2 of Repeating Form A, these deleted form records are deleted and not frozen. After you deleted Record 1 and Record 2, another sponsor user freezes the entire Repeating Form A. You can still restore deleted Records 1 and 2, despite the entire form being frozen. The form records you restore aren't frozen automatically, another sponsor user should freeze them after you restore the form records.
• If you restore deleted form records for a visit that is frozen, the visit's status remains as Frozen after the records have been restored. The restored form records will remain editable. If you restore a form record that was previously unfrozen, and you edit its data, it will not automatically refreeze.
• If a form record is unlocked or unfrozen before you delete it, its status (Unfrozen and Unlocked) is displayed in the Answer & Visit History sidebar.
• If you restore a record that was previously unlocked, unsigned, unverified, or unfrozen, their corresponding icon won't show up next to the question.