Locking & Unlocking a Study


During 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.

Accessing EDC Tools

To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.

Access EDC Tools from the Tools Tab

By default, once you open EDC Tools, Vault displays a list of automated deployment Studies. You can use the Automatic and Manual radio buttons to switch between these listings. Select Manual to access your manual deployment Studies.

Select Automatic or Manual

For manual deployment Studies, click on the Study to open EDC Tools for that Study. For automatic deployment Studies, click on the Study to open the Deployments page. From here, you can click on an Environment to open EDC Tools for that study environment.

Once you’ve entered the EDC Tools area, select your Study if you have access to more than one Study. To return to the study list, click Back to Study Listing.

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. 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

How to Lock a Manual Deployment Study

To lock a Study:

  1. Navigate to Tools > EDC Tools.
  2. Locate the Study you want to lock in the Study listing.
  3. From the Actions menu, choose Lock.
    Lock Study Action

  4. In the Lock Study confirmation dialog, click Confirm.

Your Study is now locked. Vault displays a Lock icon next to the Study inside of EDC Tools.

Locked Study in Study Listing

Disabled Actions

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

  • Update the Site’s casebook version
  • Initiate Query Rules jobs
  • Run casebook amendments
  • Edit or create new Sites
  • Add or remove Study Countries
  • Create or edit data or Casebooks associated with this Site.
  • (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

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
  • Create and edit users and their access

Data entry users may still view audit trails and export PDFs from within the Data Entry tab.

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 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 Unlock a Manual Deployment Study

To unlock a Study:

  1. Click to open Tools > EDC Tools.
  2. Locate the Study you want to unlock in the Study listing.
  3. From the Actions menu, choose Unlock.
    Unlock Study Action

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

Your Study is now unlocked, and sites can resume data collection.

Site-Level Lock

You can also lock and unlock individual Sites when you don’t need to lock an entire Study. See Managing Sites in EDC Tools for details.

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 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
Functional Permission EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission Manage Study Lock

Ability to lock and unlock Studies and Sites from EDC Tools

Learn more about Study Roles.

Profile Permissions

You must have the EDC: Study Tools: Access permission to access the EDC Tools area.


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