Close and lock a study

What this is, and who it is for#

At the end of a study the data is frozen for analysis. The path is: close to enrollment, complete, lock the database, and eventually archive. Locking and unlocking take two different people, each with an electronic signature, after both have seen the same list of what is still open. Archiving is the last step and is final.

Held by: Organization Admin, Project Manager (study.lock).

Held by: Organization Admin (study.archive).

Where to find it#

The state chip in the study header: Change study state. A pending request shows a banner on the study: A request to lock this study is waiting for confirmation, with Review and confirm and Withdraw request. The study's Lock readiness report (Use the reports and the dashboard) shows the same list in advance.

What you can do#

1. Get ready#

Complete the study first (state Completed). Then work down what the lock will list:

• Queries: answer and close every query (Work with queries). Open, reopened and escalated queries all count.
• Serious adverse events: send every initial report and reconcile each with the safety database (Review a serious event).
• Signatures: sign the records the investigators should sign (Sign records).
• Source data verification: verify the planned datapoints (Monitor and verify data).

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2. Request the lock (person one)#

Choose Lock database. The dialog is Lock the database — step 1 of 2: You are asking to lock this study's database. It takes two different people, each with an e-signature: you sign now, and a second authorised person confirms. Nothing changes until they do.

It shows Still open on this study (N) or Nothing is open — ready to lock:

When something blocks, the dialog says The study cannot be locked yet with each reason and offers only Close. Otherwise tick I have reviewed what is still open ("I understand it stays as it is if the database is locked"), give the Reason for locking, take the step-up code the system e-mails you, type your name, and choose Sign and request lock. Your signature carries the meaning responsibility. The study does not move: a request is recorded with your reason and the listing you saw.

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3. Confirm the lock (person two)#

A different person with study.lock sees the banner and chooses Review and confirm. The dialog is Confirm: lock the database — step 2 of 2: A request to lock this study's database is waiting for you. Your e-signature confirms it, and the study locks at once. It shows the request (who, when, the reason) and the listing now; if it has changed since the request it says what moved. They tick the acknowledgement, add Your comment, take a code, type their name and choose Sign and lock database. Their signature carries the meaning approval. The study becomes Locked.

If the listing changed while they were signing, the dialog says What is open on this study changed while you were signing. The list above is now current: review it and sign again. The server compares the fingerprint of the list each person saw with its own and refuses a signature made on a stale page.

The person who made the request cannot confirm it: the dialog offers them no confirm.

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4. Withdraw a request#

Withdraw request (the person who asked, or any holder of study.lock) ends the request with a reason: The request ends and the study stays as it is. Anyone may ask again. The request, its signature and your reason stay on record. A request does not expire; withdrawing is how one ends other than by confirmation.

5. After the lock#

Every write is refused: The study database is locked; no changes are permitted. Reading, reports and exports remain. Nothing in the interface is a back door: a correction needs an unlock.

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1. The state of the study: Locked.

6. Unlock#

Unlock database works the same way, two people, two signatures, with a reason: Unlocking returns the study to Completed, where data is corrected only by answering a query. Nothing blocks an unlock.

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1. The first of two signatures; nothing changes until a second person confirms.

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7. Archive#

Archive study (Organization Admin, who holds study.archive) is offered in the state menu of a Locked study, beside Unlock database. The dialog, Archive this study?, says: The study becomes read-only and is kept for retention. This cannot be undone from the interface. It asks for a Reason (required; Recorded in the study's audit trail.) and for nothing else: unlike the lock and the unlock, archiving is one person, one action, with no second signature and no one-time code. Only a Locked study can be archived, and an archived study refuses every change (The study is archived and read-only.).

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1. Archive study is offered only from the Locked state.

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1. The only thing asked for: a reason, recorded in the study's audit trail.
2. Archives the study for good. Not pressed for this picture.

8. After the archive#

The Studies list shows the study with an Archived state, and the summary counts it (1 completed · 1 archived). Its overview shows the state as a plain Archived tag, no longer a menu: no state action is offered, and nothing takes the study back. The study's health, its versions, Documents, Exports and Audit Trail stay open for reading, and the audit trail keeps every step that led here, including the lock, the unlock and the archive, each with its reason.

The overview of a Locked or an Archived study offers neither Edit study nor Start amendment: the study's settings and its versions can no longer be changed, and the server refuses both if they are asked for another way (The study database is locked; no changes are permitted. on a Locked study, The study is archived and read-only. on an Archived one). On a Completed study Edit study is still offered and Start amendment is not.

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1. An archived study stays in the list.
2. The summary counts completed and archived studies.

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1. Archived is a plain tag: no state action is offered, and no Edit study beside it.

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1. The archive is the latest event, with its reason.

Every option#

What each person signs#

Each signature needs a fresh code valid for that act, and the typed name.

What the system records#

study.lock.initiated, study.lock.confirmed, study.unlock.initiated, study.unlock.confirmed, study.state.request.cancelled (the request kept with its reason), study.state.changed, the signatures (signature.applied) and the step-up checks. See Audit events.

What you cannot do, and why#

• Lock with a query open, an overdue serious event report or an unreconciled one. A lock freezes the data for analysis, so these must be settled first.
• Confirm your own request. Two people are the point.
• Sign on a list that has changed. The fingerprint check refuses it.
• Write to a locked study, by any route, or undo an archive.
• Lock a study that is not Completed.

Compliance Q&A#

Related#

Change the state of a study · Use the reports and the dashboard · Work with queries · Review a serious event · Sign records · Statuses