Closing a study: stages and the lock

Enrolment closed, soft lock, database lock: what each allows, the signed move, going back.

A study does not close in one step. First enrolment stops, then the data are frozen for the last review and the investigators' signatures, and only then is the database locked. YouEDC Capture follows these stages: the project administrator moves the study from one to the next in Settings → Study stage, and every move is signed.

Each stage closes a little more. Viewing, the casebook and export stay open to the end.

The four stages

• Enrolling: the study is launched; sites enrol patients and enter data.
• Enrolment closed: no new patients. Data entry, queries, SDV and signatures go on for the patients already in.
• Soft lock: data and the eCRF are frozen. Investigators cannot change forms, nobody can import, randomise or change the design. Monitors raise queries and do SDV, sites answer queries, investigators sign. A data change found in the review needs the soft lock lifted.
• Database locked (hard lock): nothing changes any more. Data can be viewed, printed as a casebook and exported.

Moving the study

1. Open Settings of the study and find the Study stage section. The current stage is marked on the left.
2. Choose where to move the study. Usually it is the next stage, but you may skip one, for example lock the database straight away for an interim analysis.
3. Write the reason: “enrolment target reached”, “final analysis”, “late SAE data”.
4. Enter your password. It is your electronic signature of the move.
5. Press Sign and move.

Only the project administrator moves the study. Investigators, monitors and data managers see the stage in the study badge and get a clear message when an action is closed at this stage.

REG-DIAB-01 after enrolment was closed: what is still open before the soft lock and the lock, the form for the next move and the stage history with the signature.

Open work before a lock

Before the soft lock the section counts open queries and forms in progress. Before the hard lock it also counts complete forms without SDV, patients still taking part and, when the study uses investigator signatures, patients whose data are not signed. Each number links to the list behind it.

These are warnings, not a ban: a study may be locked with open work, for example for an interim analysis. Then tick “I know that some work is still open”. The counts are kept with the move and in the audit trail, so it is always clear what was open at the lock.

Moving back

Any stage can go back, with the same reason and password. A typical case is late SAE data after the lock: database locked → soft lock to see the data in review, then soft lock → enrolment closed to correct the form, and forward again. Earlier moves and their signatures stay in the history.

What is recorded

• Stage history under the form: when, from which stage to which, the reason and who signed.
• Audit trail: “Study stage”, “Database locked” and “Database unlocked”, with the old and new stage, the reason and the open work.
• Signature: the signer's name and role, the time, the meaning “Study stage change” and the SHA-256 of the move's audit record. That record is chained to the whole history before it, so the signature covers the study as it was at the move (21 CFR Part 11 §11.50, §11.70).
• Trial Master File: the lock and unlock records go to the TMF inbox.