Freeze and unfreeze data at the subject level

Sponsor users can now freeze all data for subject at once, freeze subjects in bulk, and permanently unfreeze a subject to support data clearing for site users.

Details for data managers and other sponsor users

In some cases, your study may call for many instances or all subject data to be frozen. For example, once a subject completes a study, you may be required to freeze all the subject's to prevent further data from being entered while the subject completes a final review to determine whether or not the subject is ready to be locked.

As a sponsor user, here's what's new for you:

• All data for a subject can be both frozen and unfrozen at once. Once the data has been unfrozen, it does not automatically refreeze at any level (form, visit, or subject).
• The Freeze option is only available if there are questions on that visit that can be frozen, while the Unfreeze option can is only available if there are questions on the visit that can be unfrozen.

  Note:

  The Unfreeze option is no longer available at the item level.
• Questions and the Visit Start Date are no longer automatically refrozen after the response is changed, even when Unfreeze is performed at the question level.
• If a question is unfrozen in a visit, the form, visit, and subject statuses are updated to Unfrozen until the question is frozen again.
• Any questions frozen in a visit where no data is entered for the visit requires the visit to be unfrozen before a user can skip the visit.
• Any newly added or restored repeating form after the visit or subject is frozen results in the visit or subject updating to a status of Never Frozen.
• Data managers now have the ability to freeze and unfreeze subjects and visits in bulk.

  Note:

  When a question is unfrozen and then the visit or subject is unfrozen, the question does not auto-refreeze.

  When a question is unfrozen and the visit or subject is frozen, the question is refrozen.

• On the Subjects and Visits pages, you can filter by Frozen and Not Frozen.

  Note:

  Filtering by Not Frozen shows both unfrozen and never frozen data.

More information on appropriate permissions and step-by-step instructions can be found the in the Add Users Guide and Sponsor and CRO User Guide after the upgrade completes.

Details for site users

As a site user, you now have the ability to clear data at the question level, even when the question was previously frozen, allowing you to correct and remove data. Here's what's new for you:

• The Reset option is no longer available for radio button questions. Instead, the Clear option is now available for any question that is currently unfrozen. Once performed, the Freeze status for that question is permanently removed.
• Clearing at the form level clears questions that are in a status of Unfrozen.
• When Clear is performed for a question on a parent question, the child questions or form are cleared if there is any unfrozen data in the questions or form.

More information on appropriate permissions and step-by-step instructions for clearing at the question level can be found in the Add Users Guide and Site Users Guide after the upgrade.

Impact on reports, extracts, archives, and datasets

Reports	Type of change	Description
Subject Events report	Modified column data	The following new event types have been added to the report: Subject Frozen Subject Unfrozen Visit Frozen (previously "Frozen) Visit Unfrozen (previously "Unfrozen")
Subject Data report	Modified column data	This report now reflects subject freezing and unfreezing actions at the Item level.

Already working in a live study?

Once the upgrade for this release is complete, freezing and unfreezing actions of all data at the subject level is available for new and existing studies. Data that was frozen prior to the upgrade is eligible to be unfrozen using the permanent unfreeze actions, and can be cleared if desired.