Mark as Blank / Intentionally Left Blank

Forms and individual data fields can be marked as intentionally left blank to let the sponsor know that the data wasn’t collected and why. Marking an item as intentionally left blank prevents Vault from generating any system queries against it. If you select Intentionally Left Blank for a field which already contains a value, Vault will prompt you to clear the existing value. To undo the Intentionally Left Blank action, click Edit. If you or another data entry user resets the form, Vault clears the Intentionally Left Blank / Mark as Blank field.

!Selecting Mark as Blank should be used sparingly and only when there is a valid reason for not entering the data as indicated in the database. Examples for valid reasons may include, but are not limited to: subject missed visit, subject missed lab appointment, subject withdrew consent, a result or date is unknown (i.e. subject visited local clinic and study site has no access to records), etc. At no time should this feature be used to circumvent normal data entry procedures for data that is present in the subject’s medical record and is required to be entered in the database.

Forms
To mark a Form as blank:

1. Click the Mark as Blank button in the upper right corner (next to the Submit button).
2. In the dialog, select a reason why the form is being marked as blank from the drop-down list.
3. If your study design allows, you can select Other (please specify) and enter your own reason in the text field.
4. Click Save.
   

Data Field
To mark a Data Field as Intentionally Left Blank:

1. Select Intentionally Left Blank from the data field’s Actions menu.
2. In the dialog, select a reason why the data wasn’t collected from the drop-down list.
3. If your study design allows, you can select Other (please specify) and enter your own reason in the text field.
4. If the data field is on a form that was already submitted, you must also enter a change reason code.
5. Click Save.
   
   

Behavioral Rules
The following behavioral rules apply when you mark a data field or form as Intentionally Left Blank:

• When you mark a Form as blank and select a reason, Veeva EDC automatically marks all Items on the form as Intentionally Left Blank and gives the reason that you selected. If any data fields were previously marked as Intentionally Left Blank and a reason was selected, Veeva EDC updates those data fields to use the new reason entered for marking the form as Intentionally Left Blank.
• When you mark or unmark a data field or form as Intentionally Left Blank, Veeva EDC automatically removes any completed Data Management Review (DMR) or Source Data Verification (SDV) from the Item or Form.
  

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