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

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. 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 Actions menu, select Freeze Form. This option is only available if the Form is not already frozen or locked.
    Freeze Form Action in the Data Entry Tab

  3. The Freeze Form dialog opens. Click Freeze.
  4. To unfreeze the form, select Unfreeze Form from the Actions menu.

To freeze an event:

  1. On the casebook schedule, scroll to the Event you want to freeze,
  2. From the More Actions menu for the event, select Freeze Event. This option is only available if the Event is not already frozen or locked. Freeze Event

  3. The Freeze Event dialog opens. Click Freeze.
  4. To unfreeze the Event, select Unfreeze Event from the Event’s More Actions menu.

To freeze a subject:

  1. From the Casebooks-level Actions Menu, open the Subject you want to freeze.
  2. From the Actions menu, select Freeze Subject. This option is only available if the Subject is not already frozen or locked.
    Freeze Subject Action in the Data Entry Tab

  3. Vault opens the Freeze Subject dialog. Click Freeze.
  4. To unfreeze the subject, select Unfreeze Subject from the 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 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 Actions menu.

To lock an event:

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

To lock a subject:

  1. From the Casebooks-level Actions Menu, open the Subject you want to freeze.
  2. From the Actions menu, select Lock Subject. This option is only available if a subject is not already locked or frozen.
  3. The Lock Subject dialog opens. Click Lock.
  4. To unlock, select Unlock Subject from the locked subject’s 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 Coordinator 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 Data Entry Tab

Ability to access the Data Entry 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
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.