This page explains how to unlock study sites and studies in eCOA Vault to allow data to be updated if needed.
You can unlock the study and sites as needed to allow data to be collected or modified. 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 |
Unlocking a Study
Complete the following steps to unlock a study that is Locked:
Note: A study cannot be unlocked while End-of-Study Media is being generated.
- In eCOA Vault, open the locked study record.
- Select Unlock Study.
- Select Complete in the task banner.
- Follow the prompts to confirm your selection.
The Lifecycle State updates to Unlocked.
Enabled Actions on Unlocked Studies
When a study is unlocked, Sponsor/CRO users with appropriate permissions can do the following actions:
- Edit the study in eCOA Vault
- Create, edit, and delete study countries and study sites
- Unlock study sites
- Add users to the study or its sites
- Make changes in Studio
Note: End-of-Study Media can no longer be generated.
Unlocking Sites
Unlocking Study Sites
You can unlock a locked study site if data needs to be updated or if data received after the lock needs to be accepted.
Complete the following steps to unlock a site:
Note: The study must be unlocked before you can unlock a site.
- In eCOA Vault, open the Study Site record.
- Select Unlock Site.
- Enter a Site Unlock Reason for Change.
- Select Start.
The Lifecycle State updates to Unlocked.
Enabled Actions on Unlocked Sites
When a site is unlocked the following actions are enabled:
- Site users with unlocked access:
- Complete most actions that their study role allowed when the site was active. An existing participant’s Participant ID cannot be changed when a site is unlocked.
- View and activate pending study versions. New study version notifications will not be sent to site users.
- Submit data change requests to Veeva.
Note: Site users without unlocked access will have the same view-only access as when the site was locked.
- External systems can create or update participant records when the site is unlocked. An existing participant’s Participant ID cannot be changed when a site is unlocked.
- Sponsor/CRO users:
- Create site users who can update data on the unlocked site by selecting the Access Unlocked Site? checkbox. This field can only be seen and edited when the site's Veeva eCOA Lifecycle State is Unlocked.
- Work with Veeva to accept data that was received while the site was locked.