Freezing & Locking Data in the Review Tab


During a study, you may need to preserve data in its current state. In Vault EDC, you can freeze or lock data that you need to preserve. Locking or freezing data can be useful before or after data review activities.

This article describes freezing and locking data from within the Review tab. For details about freezing and locking data from the Data Entry tab, see Freezing & Locking Data in the Data Entry Tab.

This feature may not be enabled in your vault. Contact Veeva Support to enable the Review tab.

Frozen data cannot be modified, but all other activities, like signatures, queries, or source data verification, can still occur. Locked data cannot be modified, and no other activities can occur on the data. Vault displays the Frozen and Locked status of Events and Forms in the Review tab.

Frozen Event in the Review Tab

Note that you can’t freeze or lock Derived-type Items.

Data Freezing

Freezing data prevents any data changes, but it allows other data management processes to continue. All actions on frozen data are included in the audit trail.

To freeze an item:

  1. Navigate to the Item you want to freeze.
  2. From the More Actions menu, select Freeze Item. This option is only available if the Item is not already frozen or locked.
  3. The Freeze Item dialog opens. Click Freeze.
  4. Vault freezes the item. To unfreeze an Item field, select Unfreeze Item from the More Actions menu.

To freeze a form:

  1. Navigate to the Form you want to freeze.
  2. From the More Actions menu, select Freeze Form. This option is only available if the Form is not already frozen or locked.
  3. The Freeze Form dialog opens. Click Freeze.
  4. Vault freezes all items on this form. To unfreeze the form, select Unfreeze Form from the More Actions menu.

To freeze all forms in an event:

  1. Click to open the Event.
  2. From the More Actions menu, select Freeze Event. This option is only available if the Event is not already frozen or locked.
  3. The Freeze All Forms dialog opens. Click Freeze.
  4. Vault freezes all forms for this event. To unfreeze the Event, select Unfreeze All Forms from the More Actions menu.

To freeze an event date:

  1. From the Event listing, scroll to the Event you want to freeze.
  2. Click to open the Event.
  3. From the More Actions menu for the Event date, select Freeze Event Date. Freeze Event Date

  4. The Freeze Event Date dialog opens. Click Freeze.
  5. Vault freezes the Event date. To unfreeze the Event, select Unfreeze Event Date from the More Actions menu.

To freeze all forms in a subject casebook:

  1. From the Casebook, select Freeze Subject from the More Actions menu. Freeze Subject Action in the Review Tab

  2. Click Freeze.
  3. Vault freezes all forms for this subject. To unfreeze the subject casebook, select Unfreeze Subject from the More Actions menu.

Available Actions

The following actions are available on frozen data:

  • Source Data Verification
  • Data Management Review
  • eSignature
  • Query-related actions

Data Locking

Locking data prevents any changes or any actions from occurring on the form or event until the form or event is unlocked. When an item is data locked, it is in a read-only state. Note that the audit trail is still accessible.

You can lock data at the form level.

To lock a form:

  1. Navigate to the Form you want to lock.
  2. From the More Actions menu, select Lock Form. This option is only available if a form is not already locked or frozen.
  3. The Lock Form dialog opens. Click Lock.
  4. To unlock, select Unlock Form from the locked form’s More Actions menu.

To lock all forms in an event:

  1. On the casebook schedule, scroll to the Event you want to lock.
  2. From the More Actions menu, select Lock Event. This option is only available if the data is not already locked.
  3. The Lock All Forms dialog opens. Click Lock.
  4. To unlock the Event, select Unlock All Forms from the More Actions menu.

To lock an event date:

  1. From the Event listing, scroll to the Event you want to lock.
  2. Click to open the Event.
  3. From the More Actions menu, select Lock Event Date.
  4. The Lock Event Date dialog opens. Click Lock.
  5. Vault locks the Event date. To unlock the Event, select Unlock Event Date from the Actions menu.

To lock all forms in a subject casebook:

  1. From the Event listing, select Lock Subject from the More Actions menu.
  2. Click Lock.
  3. Vault locks all forms for this subject. To unlock the subject casebook, select Unlock Subject from the More Actions menu.

Status Icons

Icon

Meaning

Frozen Icon

The Event, a Form within the Event, or an Item on a Form is currently in the Frozen status.

Locked Icon

The Event or a Form within the Event is currently in the Locked status.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard CDMS Data Manager and CDMS Clinical Research Associate application roles can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Functional Permission Review Tab

Ability to access the Review tab

Functional Permission Freeze Data

Ability to freeze and unfreeze data

Functional Permission Lock Data

Ability to lock and unlock data

Learn more about Study Roles.

Profile Permissions

Freezing actions are available to the EDC CRA and EDC Lead CRA security profiles. Locking actions are available for the EDC Data Manager and EDC Lead Data Manager security profiles.

If your vault uses custom security profiles, you must have the following permissions to perform these tasks:

Type Permission Controls
Security Profile Tabs: Review Ability to access the Review tab.
Freezing
Security Profile Object: Event: Review for Frozen: Edit Ability to freeze and unfreeze an Event. Freezing an Event sets this field to Yes.
Security Profile Object: Form: Review for Frozen: Edit Ability to freeze and unfreeze a Form. Freezing a Form sets this field to Yes.
Security Profile Object: Item: Review for Frozen: Edit Ability to freeze and unfreeze an Item. Freezing an Item sets this field to Yes
Locking
Security Profile Object: Event: Review for Locked: Edit Ability to lock and unlock an Event. Locking an Event sets this field to Yes.
Security Profile Object: Form: Review for Locked: Edit Ability to lock and unlock a Form. Locking a Form sets this field to Yes.

Learn more about permission sets