Locking Studies & Sites

Over the course of your Study, you may need to lock down the entirety of your Study, instead of only an Event or Form. Locking a Study puts your Study in a read-only state, until you unlock it. You can lock a Study while in progress for interim analysis, safety issues, or if your study is put on hold, or you can lock your Study after data collection is complete.

Prerequisites

Required Permissions

Users with the standard CDMS Lead Data Manager application role and a Security Profile that grants access to the EDC Tools 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
Standard Tab EDC Tools Tab

Ability to access the EDC Tools tab
Functional Permission Manage Study Milestones

Ability to lock and unlock Studies and Sites, as well as set the Billing Status for study environments from EDC Tools

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 Study Environment

To lock a study Environment:

  1. Navigate to your Study in Tools > EDC Tools > Deployments.
  2. Locate the Environment you want to lock in the listing.
  3. Hover over the Environment to show the Actions menu.

  4. From the Actions menu, select lock_outline Study Data Lock. Lock action

  5. In the Lock Study confirmation dialog, click Lock.

Your environment is now locked. Vault displays a Lock icon () next to the environment in EDC Tools > Deployments.

Lock icon

Disabled Actions in Locked Studies

When a Study is locked, no users can perform any of the following actions:

  • Add new Casebooks
  • Enter data in Casebooks (CRFs)
  • Add new instances of repeating Event Groups, Forms, or Item Groups
  • Add new Unscheduled Events
  • Provide signatures
  • Open, answer, or close queries
  • Post queries (Coder)
  • Perform SDV or DMR
  • Create or update Protocol Deviations
  • Perform any coding activities in Vault Coder
  • Update the Site’s casebook version
  • Run casebook amendments
  • Edit or create new Sites
  • Add or remove Study Countries
  • (Environments only) Delete the Study Environment
  • (Environments only) Deploy the Study Environment into another environment
  • (Environments only) Deploy into the locked environment from another environment
  • (Environments only) Rename the Study Environment
  • (Environments only) Delete study data in the Study Environment
  • (Environments only) Restore the Study Environment

Study administrators may still perform the following:

  • Initiate the Detail PDF and Data Export jobs
  • Export a list of users to CSV
  • Add or edit Connections
  • Create and edit users and their access

Site and review users may still view audit trails and export PDFs from within the Data Entry and Review tabs.

How to Unlock a Study Environment

To unlock an environment:

  1. Navigate to your Study in Tools > EDC Tools > Deployments.
  2. Locate the Environment you want to unlock in the listing.
  3. Hover over the Environment to show the Actions menu.

  4. From the Actions menu, select Study Data Unlock. Unlock action

  5. In the Unlock Study confirmation dialog, click Unlock.

Your study environment is now unlocked, and your data entry users can resume their work.

How to Lock a Site

From EDC Tools > Sites, you can lock or unlock a Site. Locking a Site prevents any and all changes to collected data at that site.

To lock a Site:

  1. Navigate to EDC Tools > Sites.
  2. Locate the Site you want to lock in the Site listing.

  3. From the Actions menu, select Lock. If the Site you’re locking has open Assessments, click Confirm in the Lock Site dialog. Lock Action in the Site Actions Menu

  4. Optional: In the Lock Study confirmation dialog, select Generate Closeout PDFs to automatically generate closeout PDFs for this site.
  5. Click Confirm.

Your Site is now locked. Vault displays a Lock icon next to the Site in EDC Tools.

Lock Icon on a Locked Site

How to Bulk Lock Sites

To lock multiple Sites at once:

  1. Navigate to EDC Tools > Sites.
  2. Locate the Sites you want to lock in the Site listing.

  3. Select the Sites you want to lock. Bulk Site selection

  4. Click Lock Site. Lock Site button

  5. Optional: Select Generate Closeout PDFs in the Lock Sites dialog to generate closeout PDFs for each site.
  6. Click Continue.

Disabled Actions on Locked Sites

When a Site is locked, no users can perform any of the following actions:

  • Update the Active Version for the Site
  • Run amendments in the Site
  • Edit the Site record
  • Add new Casebooks
  • Enter data in Casebooks (CRFs)
  • Add new instances of repeating Event Groups, Forms, or Item Groups
  • Add new Unscheduled Events
  • Provide signatures
  • Open, answer, or close queries
  • Post queries (Coder)
  • Perform SDV or DMR
  • Create or update Protocol Deviations
  • Update the Site’s casebook version
  • Initiate Query Rules jobs

Note that while you will still be able to initiate a Query Rules job, Vault ignores any locked Sites during execution. For example, if your Study includes two Sites, Site A and Site B, and Site A is locked, Vault will only evaluate data for Site B.

Known Issue: If a user attempts to edit an existing Protocol Deviation when the Site is locked, they will receive a server error.

EDC Tools users may still perform the following:

  • Initiate the Detail PDF and Data Export jobs
  • Export a list of users to CSV
  • Add or edit Connections
  • Manage Study Countries
  • Create and edit users and their access
  • Add new Sites to the Study

Site and review users may still view audit trails and export PDFs from within the Data Entry and Review tabs.

How to Unlock a Site

To unlock a Site:

  1. Navigate to EDC Tools > Sites.
  2. Locate the Site you want to unlock in the Site listing.

  3. From the Actions menu, select Unlock. Unlock Action in the Site Actions Menu

  4. In the Unlock Site confirmation dialog, click Confirm.

Your Site is now unlocked and can resume data collection.