Add sites

A site is a research location where subjects are actually enrolled and data is entered. Adding a site means activating it on a published design version: from then on subjects can be enrolled there.

Who and when

Data manager or Administrator — whoever holds the “activate a site” permission (site.activate); closing a site requires site.deactivate. Buttons are hidden without the permission, and the server re-checks access anyway.

The task comes up after the first design version is published (the BUILD → CONDUCT boundary), when a new location joins the study, and when enrollment at a site stops or a protocol amendment rolls out.

Before you start

• The study has at least one published design version — see Publish a version.
• You know the site code (e.g. SITE-01), its name and timezone (an IANA zone such as Europe/Moscow).
• You have opened the Sites screen: in a running study — Setup, the Sites tab (/studies/{studyId}/sites).

Steps

0:000:00

The Sites screen: statuses, design versions and activation on a published version.

1. Click Add site….

2. Enter the Site code and Site name.

3. Check the Site timezone. It defaults to your browser’s zone; date/time values of the site’s subjects are entered and shown in it. An unknown zone is flagged — pick an IANA zone from the list.

4. Choose the Design version — only published versions are listed; the newest is preselected.

5. Click Activate. The site appears in the table as Active and can enroll subjects from now on.

Different sites can run on different published versions — this is normal during amendments, when some sites have already moved to the new version and others still run on the previous one.

Close a site

1. In the site’s row, open More actions and choose Close site (site.deactivate).

2. Read the warning: subject enrollment into this site will be blocked; data of already enrolled subjects stays available.

3. Enter a reason and confirm. The site becomes Closed.

Reopen a site

Closing is reversible. In a closed site’s row, open More actions → Reopen and confirm (site.activate): the site becomes active again and can enroll subjects.

Move a site to another version

In an active site’s row, open More actions → Move to version, choose the Published version and click Move (site.activate). From now on new subjects of the site are created on the chosen version; already enrolled ones are moved by the migration plan — see Run a protocol amendment.

What happens

• The Sites table shows each site’s code, name, status, version, timezone and number of enrolled subjects.
• Activation is written to the audit trail as “Site activated” (code, version, timezone); closing and reopening as “Site status changed” with the old and new status and the reason; moving to a version as a separate event with the old and new version.
• A site status change is published as a platform event — modules can react to it.
• A closed site enrolls no subjects; already enrolled subjects and their data remain fully available for viewing, cleaning and signing.

Status	Meaning
Active	The site is running: subjects can be enrolled
Closed	Enrollment is blocked; data remains available

If it doesn’t work

• “Add site…” is disabled with the hint “Publish a design version first” — the study has no published version. Publish the design and come back.
• No buttons, or the hint “You cannot activate sites” / “You cannot close sites” — you lack site.activate / site.deactivate on this study. Ask your administrator.
• Error on adding: the site is already activated (SITE_ALREADY_ACTIVATED) — this site is already attached to the study. To change its version, use Move to version.
• Unknown timezone (INVALID_TIMEZONE) — pick an IANA zone from the list.
• A coordinator cannot enrol a subject (SITE_NOT_ACTIVE) — the site is closed. Reopen it if enrollment must continue.

Next

Publish a versionHow to bring a design to a published version that sites are activated on.

Enrol a subjectEnrollment only happens at active sites — what follows activation.

Run a protocol amendmentMoving sites and subjects to a new design version.

Roles and accessHow grants and site scope decide who activates and closes locations.

More details

Publication unlocks activation

A site cannot be activated “into a void”: it is bound to a published design version. This is the same BUILD → CONDUCT boundary as launching the study — until there is a live design, there is nothing to activate against. Activation is the only way to create a site: there is no separate “create without activating” in the product.

Site lifecycle

1. Activeclose
2. Closed
   • reopenActive

Site lifecycle: active ↔ closed; closing and reopening carry a reason and go to the audit trail.

Site code and timezone

A site as a physical location is shared across the tenant’s studies: it is created the first time its code is used and reused afterwards. If activating the same code in another study specifies a different timezone, the site’s timezone is updated (it is the same physical place — a typo fix), and this is visible in the audit trail.

Site visibility

Site visibility matches visibility everywhere else in the interface — by study.read in the scope of the corresponding site. A monitor restricted to their own locations sees only those.