Locking the Database for Sites or Studies

This page explains how to lock study sites and studies in eCOA Vault to end data collection and prevent further modifications. The locking feature in eCOA is intended for final database lock only.

You can lock individual study sites once site activities are complete. You can lock a study once all sites are locked. Users with the following combinations of Security Profiles and Study Roles can lock and unlock sites and studies:

Security Profiles System Administrator (no study role needed), Clinical Administrator, Study Team User
Study Role Study Builder, Lead Data Manager

Locking Study Sites

Locking a Single Site

Complete the following steps to lock a study site:

Important: The eCOA Site Status must be Active or Unlocked for you to lock a site.

  1. In eCOA Vault, open the Study Site record.
  2. Select Initiate Final Site Lock. The Initiate Final Site Lock dialog box is displayed.
  3. Follow the prompts to confirm your selection.

The eCOA Site Status updates to Locking. Once the process is complete, the status will change to Locked, and you will receive a notification.

To enable changes to be made to a site’s data after it is locked, you can unlock the site. You must unlock the study before you can unlock a site.

Locking Multiple Sites

Complete the following steps to lock multiple sites in the same study country at once:

  1. In eCOA Vault, open the Study Country record.
  2. Select Initiate Bulk Final Site Lock. The Initiate Bulk Final Site Lock dialog box opens.
  3. Follow the prompts to select the sites you want to lock, and select Continue.
  4. Confirm your selection.

The eCOA Site Status for all selected sites updates to Locking. Once the process is complete, the statuses will change to Locked, and you will receive a notification.

To enable changes to be made to a site’s data after it is locked, you can unlock the site. You must unlock the study before you can unlock a site.

Disabled Actions on Locked Sites

When a site is locked, the following actions are disabled:

  • Site users:
    • Create, edit, or delete participants. Active participants at the site will be deactivated automatically.
    • Work with surveys. All available surveys will be canceled and future surveys will not be made available.
    • Modify data. Any survey submissions, data changes, or removals/restores received by the server after the lock is initiated will be stored separately to be processed by Veeva at the sponsor/CRO’s request. This data will not be displayed in exports or audit trails unless the site is unlocked and the data is accepted.
    • View or activate pending study versions.
    • Receive data change request approvals from Veeva.
  • Sponsors/CRO users:
    • Edit the site in eCOA Vault.

Locking a Study

Complete the following steps to lock a study:

  1. In eCOA Vault, open the study record.
  2. Select Initiate Final Study Lock.
  3. Select Complete in the task banner.
  4. Follow the prompts to confirm your selection.

Upon confirmation, the eCOA Study Status will temporarily update to Locking. Once the process is complete, the status will change to Locked.

To enable changes to be made to the study data after it is locked, you can unlock the study.

Disabled Actions on Locked Studies

When a study is unlocked, the following actions are disabled for Sponsor/CRO users:

  • Edit the study in eCOA Vault
  • Create, edit, or delete study countries and study sites in the locked study
  • Unlock sites
  • Add users to the study or its sites
  • Make changes in Studio

Additional Resources