Locking Data

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

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

Prerequisites

Users with the standard CDMS Data Manager and CDMS Lead Data Manager can perform the actions described below by default. If your study uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Review Tab

Ability to access the Review tab

Functional Permission Lock Data

Ability to lock and unlock data

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


How to Lock a Form

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.

How to Lock an Event

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.

How to Lock a Subject

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.

Locking at the Site & Study Level

Lead data managers can lock entire Sites or Studies from EDC Tools. Locking a site or study prevents any changes or other activities for all forms within that site or study.