How does clearing data may impact my study?

When a question is cleared it gets returned to an unanswered state, with no data associated to it. This can be compared to a reset and is a change that occurs in the backend. Conversely, when a question's answer is removed, by using the Delete or Backspace keys, it replaces the answer by an empty string or value. In turn, there is still data associated to the question, just that this data is an empty answer.

Note:

Even if you clear a question's data, its whole answer history is retained. All actions performed on a question are listed on the Answer & Visit History sidebar and in the audit trail.

Impact on data collection

If you are a Clinical Research Associate (CRA), a data manager, or any other sponsor user involved in maintaining data integrity, you should know how clearing form data impacts the data collection process. Understanding the impacts on data collection is important as it may affect data review and the Source Data Verification (SDV) processes.

When you clear or remove a required question, a form's status is set to Incomplete. However, , when you clear or remove an optional question, a form's status is not impacted.
If you update a question that has an open manual query (either by updating, removing or clearing data), the query status is updated to Answered. For the case of automated queries, it always depends on the rule logic, see Impact on custom rules.
When a site user updates a question that was previously cleared, a reason for change is not provided.
All icons next to a cleared question disappear. However, the respective actions on the question (such as unsign, unverify or unlock) are listed on the Answer & Visit History sidebar.
When a site user clears a verified or signed question, it becomes unverified or unsigned, respectively. As mentioned, the Unsigned and Unverified icons do not display for the question, but the action is listed on the Answer & Visit History sidebar.
When you clear a completed visit date, the visit's status is updated to Incomplete.
When you clear a date that is used to determine lab normal ranges, the system date at the time of the update is used instead to populate the calculated values. For calculations using the visit date (like age questions), clearing the visit date results in a failed calculation and an incomplete question.

Impact on custom rules

When a question used as a rule's input is updated (cleared, removed or replaced with a new value), the system processes the change causing the impacted rule or rules to be re-run. The end result depends on the rule logic and is applicable to all types of custom rules:

Tip:

You can view the resulting actions in the Answer & Visit History sidebar, each stated as the result of rule execution.

For rules that populate calculated values, if a question used as an input for the calculation is removed or cleared, the rule re-runs with an empty value as the input. This would typically result in the calculated value also getting removed or cleared (respectively). However, you should keep in mind that the output always depends on what the rule logic dictates.

Note:
Clearing or removing a value makes it null and it is not the same as making it zero.
If a question with an opened automated query is cleared or removed, either directly or as a result of calculation rule, the query will behave according to what the rule dictates. Typically, the automated query would get Closed, but this is only if the condition for the query no longer applies and as long as the rule logic doesn't dictate differently.
For rules that raise queries or send notifications, the result of clearing the input depends on how an empty input would trigger the rule. So, only for the case of rules that raise queries or send notifications when detecting empty values, clearing a value results on a notification being sent or a query being raised against the question.

Impact on reports and data extracts

The Subject Data Extract does not include records of forms for which all data has been removed (either deleted using the Backspace key, reset or cleared).
- This also applies to when the Not Answered data flag populates for form items as a result of Source Data Verification (SDV), sign, freeze or lock actions.
The Subject Data report has an option to include or exclude cleared data available in the Settings pane on the right.
In the Subject Events Report, for the event of clearing a visit date in Oracle Clinical One Platform, a Visit Date Cleared value displays under the Event Type column.

Impact on integrations

If you're an integration manager working with Oracle Clinical One Digital Gateway, clearing data in a form only impacts the following integrations:

Integration with	Impacts of data clear
Oracle InForm	Upon data being cleared in Oracle Clinical One Platform, a clear data action is issued in Oracle InForm along with the specified reason for change.
Oracle Central Coding	When a site user clears a Verbatim or coding context item (Route of Administration or Indication) Oracle Central Coding operates as though a user has removed or updated the value in that field. The update is properly reflected in Oracle Central Coding and the new data that is entered for a Verbatim, Route of Administration, or Indication is coded as new data.
Any other third-party electronic data capture (EDC) system	Upon data being cleared in Oracle Clinical One Platform, a null value is sent through Oracle Clinical One Digital Gateway to the third-party system.

For more information, reach out to your Oracle point of contact.