What this is, and who it is for
A study has one state that says what the trial is doing now, separate from the versions of its design and from the workspaces. The state decides what the study accepts: new participants, data entry, queries, new versions. This page covers the one-person moves: hold, resume, close to enrollment and complete. Locking and archiving are on Close and lock a study.
| You need | To |
|---|---|
study.state.change | Hold, resume, close to enrollment, complete |
study.lock | Request and confirm a lock or unlock |
study.archive | Archive |
Held by: Organization Admin, Project Manager (study.state.change).
Where to find it
The state chip in the study's header (for example Active). When you may make a move, the chip is a menu (Change study state); when you may not, it is a plain chip with nothing to open. The menu offers only the moves the study is in a state to make and that you hold the permission for.
What you can do
| Move | From | To | What it does |
|---|---|---|---|
| Put on hold | Active | On hold | New subjects stop being enrolled. Data entry, queries and safety reporting continue. |
| Resume | On hold | Active | The study returns to Active and enrolment reopens. |
| Close to enrolment | Active or On hold | Closed to enrolment | No further subjects can be enrolled. Data entry for those already enrolled continues. |
| Complete study | Closed to enrolment | Completed | New data is no longer accepted: corrections are made only by answering a query, and new versions can no longer be started. A version still being built or tested must be withdrawn first. |
Choose the move; a dialog restates what it does and asks for a reason, which is required and becomes part of the study's record. Confirm with the button (Put on hold, Resume, Close to enrolment, Complete study). A toast says … done.
Every option
States
A study starts in Setup. Version 1.0 going Live takes it to Active (nobody decides that move; it is a consequence of the release, in the same transaction). From there: On hold, Closed to enrolment, Completed, Locked, Archived. The moves are stored as hold, resume, close_enrolment, complete, lock, unlock and archive. The diagram, the codes and the table of what each state accepts are on Statuses and Who can and cannot.
In short:
| State | Enroll new participants | Enter and correct data | Queries, source verification, signatures, safety, deviations | New versions |
|---|---|---|---|---|
| Setup | No | No Live data | Design work only | The first is built |
| Active | Yes | Yes | Yes | Yes |
| On hold | No | Yes | Yes | Yes |
| Closed to enrolment | No | Yes | Yes | Yes |
| Completed | No | Only by answering a query | Yes | No |
| Locked | No | Nothing is written | No | No |
| Archived | No | Read-only | Read-only | No |
(Refusals read, for example, The study database is locked; no changes are permitted.)
- The moves this role may make from the current state.
Completing
Completing is the end of data collection. Before it, finish enrollment, resolve what you can and withdraw any version still in Build or UAT. After it, a value is corrected only through a query answered with a corrected value and a reason; the participants' own status is changed on each participant (Change a participant's status).
- The state menu: from Completed the study can go to Locked.
- Still offered on a Completed study; not on a Locked or Archived one.
What the system records
study.state.changed for each move, with the old and new state, the reason, the person and the time. A two-person move (lock, unlock) has its own events (Close and lock a study).
What you cannot do, and why
- Skip a state. The moves are the ones in the table; a study cannot jump from Active to Completed.
- Move a study with no reason.
- Reopen enrollment after it was closed. Close to enrolment has no way back (only On hold and Resume do); start the work in a new study or an amendment if the protocol needs it.
- Complete with a version still in flight. Withdraw it first.
- Use the menu without the permission. The chip shows the state and nothing else.
Compliance Q&A
Yes. A state can change only by one of the defined moves, by a person who holds the permission for it, with a recorded reason; the server's table decides what each state accepts, so a screen cannot offer more.
Evidence: server/src/modules/study/studies/domain/study-state.ts (the state table, one guard)change-study-state.tsaudit event study.state.changed
Related
Close and lock a study · Statuses · Who can and cannot · Project Manager