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.

Vault shows a Locked status banner across locked Forms in the Content panel.

Locked form banner

Prerequisites

Required Permissions

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.

Disabled Actions

The following activities are disabled on locked Forms, Events, and Subjects:

Locked Forms

  • Enter data in the locked Form
  • Add new instances of repeating Item Groups if the Form containing the Item Group is locked
  • Provide a signature for the locked Form
  • Open, answer, or close queries on Items within the locked Form
  • Post queries to the locked Form (Coder)
  • Perform SDV or DMR at the item or form level on the locked Form

Locked Events

  • Enter or edit the Event Date for the locked Event
  • Enter or edit data on any Forms within the locked Event
  • Add new instances of repeating Item Groups within the locked Event
  • Add new instances of any repeating Forms within the locked Event
  • Sign at the form or event level
  • Open, answer, or close queries on the Event Date of the locked Event
  • Open, answer, or close queries on any Items within the locked Event
  • Post queries to any Forms within the locked Event (Coder)
  • Perform SDV or DMR on the Event Date for the locked Event
  • Perform SDV or DMR at the item or form level on Forms within the locked Event

Locked Subjects

  • Enter data in any Form
  • Add new instances of any repeating Item Groups, Forms, or Event Groups
  • Add new Unscheduled Events
  • Provide signatures
  • Open, answer, or close queries
  • Post queries (Coder)
  • Perform SDV or DMR

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. Lock Form action

  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. Lock Event action

  3. The Lock All Forms dialog opens. Click Lock.
  4. To unlock the Event, select Unlock Event from the More Actions menu.

Locking/Unlocking Events and Repeating Events: If a single Event is unlocked in an otherwise fully locked casebook, Sites can enter data and create new instances of repeating forms within that unlocked Event. If the unlocked Event is repeating, Sites will not be able to add additional instances of the repeating Event Group to a locked casebook. The casebook must be unlocked in order to add any additional repeating Event Groups.

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. Lock Event Date action

  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. Lock Subject action

  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.