What this is, and who it is for
A site is a place where participants are screened and enrolled. It is registered first (which lets it do nothing), then activated through a regulatory gate: a recorded ethics approval and confirmed training. Only an active site can enroll. A site belongs to one workspace: sites registered in UAT are test sites; sites registered in Live are the real ones, and they are separate records.
| You need | To |
|---|---|
site.read | See the Sites screen |
site.write | Register a site and set its enrollment target |
site.activate | Activate a site through the gate |
site.transition | Suspend, reinstate and close a site |
Held by: Organization Admin, Project Manager (site.write).
Held by: Organization Admin, Project Manager (site.activate).
Held by: Organization Admin, Project Manager (site.transition).
Where to find it
Inside a workspace: Sites (UAT or Live). The page lists the study's sites with Total, Active, Countries and Pending activation, and buttons Add site and Import. A site's own page has its details, performance figures, Staff and Documents.
What you can do
Register a site
- Choose Add site (Register a new clinical site for this study. Activation workflow (IRB approval, GCP training) is run from the site detail page once created.).
- Fill in Code (unique in the study and workspace; capitals), Site name, Country (limited to the study's countries), City, the Principal Investigator's name and email (a valid address is required), Site staff (count) and Notes.
- Choose Add site. The site is registered. The principal investigator is provisioned at the same time: the system finds or creates a site-scoped account for the address and grants it the investigator role at this site. The investigator is a site person, not a member of your Organization Team.
If the site already has its ethics approval, switch on Record IRB approval now — activate on creation: give the IRB reference, Approved on and the Approval kind, and the site is registered and activated in one step (it lands Active, or Registered if that step is refused: a toast says why).
Import many sites
Import reads a CSV file, shows which rows are valid and registers the valid ones (Imported N of M sites). Rows that fail are listed; sites registered by import land Registered.
Activate a site
On the site's page choose the lifecycle menu → Activate site: Confirm regulatory and operational prerequisites are complete. After activation, the site can begin screening and enrolling subjects.
| Field | Notes |
|---|---|
| IRB / IEC approval date | Required |
| IRB protocol number | The committee's reference; required (the activation needs a recorded approval reference and date) |
| Activation date | The first date the site may screen; defaults to now |
| GCP prerequisite: Protocol training complete | PI, sub-Is, coordinators have completed protocol-specific training (ICH E6 — investigator must be qualified before the trial starts). Must be ticked |
| Activation notes | Optional |
Without a recorded approval and the training confirmation the server refuses (A recorded IRB/IEC approval is required to activate a site; GCP training must be complete to activate a site).
- Disabled until every requirement is given.
Suspend, reinstate, close
Move site to another state: a suspended site (reason required) can be reinstated or closed; an active site can be suspended or closed; close is final and needs a reason. A registered site can only be activated through the gate above, not by "resume".
Set an enrollment target
On the site's page, Enrolment target (Not set until you save a number).
Every option
Site states
| From | Can move to |
|---|---|
| registered | active, closed |
| active | suspended, closed |
| suspended | active, closed |
| closed | (none: final) |
| State | Meaning |
|---|---|
| registered | Exists, can do nothing |
| active | Can screen and enroll. Needs approval, training |
| suspended | No new screening or enrollment; data entry on existing participants is decided by the study's state |
| closed | Final |
Before the first release
The first go-live of a study needs at least one active Live site with an investigator at every active one (Sign off a version and go live). A site's investigator is added at registration; its other staff are added next (Staff a site).
What the system records
site.registered, site.activated (with the approval reference and date and the training confirmation), site.transitioned (with the reason), site.target_set, and the principal investigator's role assignment. See Audit events.
What you cannot do, and why
- Enroll at a site that is not active. Enrollment is blocked until the site is activated (IRB approval recorded).
- Activate without an approval or training. The gate is the point.
- Reuse a site code in the same study and workspace.
- Move a UAT site into Live. They are separate records in separate workspaces.
- Reopen a closed site.
Compliance Q&A
No. A site is registered with no ability to enroll and becomes active only through the gate that records the approval's reference and date and the training confirmation, in one audited act; no other transition reaches active.
Limits: the system records the approval; whether the ethics committee's decision covers the current protocol version is the site's file, not checked here.
Evidence: server/src/modules/study/sites/domain/site.ts (activate: approval reference and date, and GCP training, required)transition cannot bypass the gate
Related
Staff a site · Sign off a version and go live · Screen a participant · Project Manager · Statuses